Drug companion protocol
CagriSema (combination)
Active ingredient: Cagrilintide
A long-acting amylin analogue under clinical investigation for weight management, including in combination with semaglutide.
Quickstart Highlights
- Drug class
- Amylin analogue
- Route
- Subcutaneous injection
- Schedule
- Weekly subcutaneous injection
- Evidence score
- 45
Quickstart highlights
- 💉Subcutaneous injection
- 🔬Amylin analogue
- 📋Prescription required
How this works
Mechanism of action and pharmacokinetic profile from published data.
Cagrilintide is a long-acting analogue of amylin — a hormone co-secreted with insulin from pancreatic beta-cells. Amylin slows gastric emptying, suppresses post-meal glucagon secretion, and signals satiety in the brain via area postrema receptors — a complementary pathway to GLP-1 agonism. Because amylin and GLP-1 work through different pathways, combining cagrilintide with semaglutide (as "CagriSema") may produce additive weight loss beyond either agent alone. Phase 2 data support this hypothesis; Phase 3 trials are ongoing.
Half-life
7 days
Tmax
3 days
Duration of action
7 days
- Time to peak (Tmax)
- ~3–4 days after subcutaneous injection.
- Clearance
- Degraded via proteolytic pathways — specific clearance data from published Phase 2 trials.
- Elimination half-life
- Approximately 7 days, supporting once-weekly subcutaneous dosing (reported from Phase 1/2 data).
- Bioavailability
- Data from investigational Phase 2 studies; not yet on a product label.
Dosing overview
Structured dosing phases exposed through the public drug API.
Cagrilintide Phase 2 reference
| Phase | Dose | Frequency | Guidance |
|---|---|---|---|
| Trial titration varies Week 0+ | Protocol specific | once weekly | Investigational amylin analogue; dose escalation differs across trials and combinations. Follow the active trial protocol rather than a public protocol table. |
Your journey
Where you are in a typical protocol, and what one dose cycle looks like. Educational — your prescriber tailors the plan to you.
Protocol timeline
Maintenance phase
Weeks 17+4.5 mgevery 7dWhat to expect: Dose held at maximum tolerated level per trial protocol, GI side effects often stabilise at maintenance, Sustained appetite suppression and weight-related changes expected, Ongoing monitoring by trial site for safety and efficacy endpoints
Focus on: Focus on sustainable eating and movement habits, Continue weekly self-monitoring and trial check-ins as required, Keep all scheduled trial-site appointments — do not adjust dosing independently, Discuss any changes in health status (new medications, illnesses, pregnancy planning) with your trial prescriber immediately
Common adjustments: Dose may be individualised to highest tolerated level rather than fixed maximum, Regular trial-site assessments (bloods, vitals, imaging) will continue
Starter phase
Weeks 1–40.3 mgevery 7dWhat to expect: Body adjusting to amylin-pathway signalling, Possible early reduction in appetite and post-meal fullness signals, Mild nausea or stomach discomfort most likely in this phase, Gastric emptying may begin to slow noticeably
Focus on: Learn correct subcutaneous injection technique with your trial nurse, Track nausea, appetite, and energy at each weekly check-in, Eat smaller, lower-fat meals to support GI comfort, Stay well hydrated throughout the week
Common adjustments: Trial protocol may hold dose if GI side effects are poorly tolerated, Injection-site reactions (redness, mild swelling) are common early on — rotate sites as instructed
First escalation
Weeks 5–80.6 mgevery 7dWhat to expect: Appetite suppression may become more pronounced, Weight loss (if applicable) may begin to be measurable, GI symptoms (nausea, constipation) may re-emerge briefly after dose increase, Satiety signals after meals likely stronger
Focus on: Continue small-portion, low-fat eating pattern, Monitor bowel habits — aim for at least 3 motions per week, Report any persistent vomiting or inability to tolerate fluids to your trial site promptly, Record your weekly weight if instructed by the trial protocol
Common adjustments: Dose escalation may be delayed by trial site if tolerability threshold not met, Constipation management strategies may become relevant at this stage
Second escalation
Weeks 9–121.2 mgevery 7dWhat to expect: Further appetite suppression expected, Continued or accelerated weight changes, GI side effects may recur transiently with escalation, Energy levels may fluctuate as caloric intake adjusts
Focus on: Prioritise protein and micronutrient-dense foods to support reduced intake, Discuss any significant energy reduction or fatigue with your trial team, Continue weekly symptom logging
Common adjustments: Some participants may remain at 0.6 mg if tolerability warrants, Trial nutritionist or dietitian referral may be offered at this stage
Third escalation
Weeks 13–162.4 mgevery 7dWhat to expect: Appetite suppression likely near maximal, Risk of nausea and constipation highest during this escalation step, Weight trajectory may steepen, Glucagon suppression effect may be more noticeable post-meal
Focus on: Maintain consistent hydration — at least 1.5–2 L of water per day, Eat mindfully; do not skip meals entirely even if appetite is very low, Alert your trial team to any new or worsening symptoms
Common adjustments: Dose may be maintained at 1.2 mg if GI tolerability is a concern, If combining with semaglutide (CagriSema trial), overlapping GI effects may be more pronounced
One dose cycle at a glance
Population typicals, in hours from your dose — individual experience varies.
Onset
24 h
Peak effect
72–96 h
Appetite effect
24–168 h
Nausea risk
12–96 h
Constipation risk
24–168 h
Coverage fades after
168 h
DRAFT — sourced from Phase 1/2 investigational data only; no approved product label exists. tmax approximately 72–96 hours (3–4 days) after subcutaneous injection. Half-life approximately 7 days supports once-weekly dosing. Nausea risk appears highest around and shortly after peak plasma concentration. Appetite suppression and constipation risk are distributed across the full weekly dosing interval. All windows are population-typical estimates for educational purposes only and must be verified against published trial data by a clinical editor before publication.
Clinical Benefits & Side Effects
Observed outcomes, adverse effects, and lifecycle considerations from published trial data.
Benefits
Starting in a trial context
Cagrilintide is only available in clinical trials as of 2024–2025. It has been studied primarily as part of the CagriSema combination (with semaglutide). The dose-escalation protocols vary by trial.
First injection — taking the first step
This is your first week, and just starting is something to feel good about. You may not notice much physically yet — that's completely normal at this early, low dose. Some people feel mild nausea or a reduced appetite, while others feel little to nothing different.
Body beginning to adjust to the medication
Your body is still getting used to cagrilintide, and side effects like mild nausea, reduced appetite, or tiredness may come and go. Don't be discouraged if you don't see changes on the scale — the early weeks are about building a foundation, not dramatic results.
Navigating early side effects with more confidence
By now you may have developed a feel for how your body responds around injection day. Nausea, if present, often peaks within the first day or two after your injection and then eases. Small, frequent meals and staying well hydrated can make a real difference this week.
Completing your first month — building consistency
Reaching four weeks is a genuine milestone — consistency now is laying the groundwork for everything ahead. Many people are still in a low-dose adjustment phase and haven't seen major weight changes yet, and that's expected. Focus on locking in good habits around food, hydration, and movement.
Dose may increase — appetite changes become clearer
If your prescriber has scheduled a dose increase, you may notice appetite suppression becoming more noticeable this week. Some people find they feel satisfied with smaller portions almost without trying — lean into that, but make sure you're still eating enough nutritious food.
Appetite suppression making meals feel different
Food may feel less urgent or less exciting than it used to — this is the medication working as intended. It's a good time to focus on eating slowly and mindfully, so you can tune in to your body's genuine hunger and fullness signals. Side effects often start to ease as your body adapts.
Finding a rhythm with food and movement
Many people start to feel more settled this week and find it easier to plan meals and stay active. If nausea has been a challenge in earlier weeks, you may notice it's becoming more manageable. This is a great time to build or strengthen a gentle exercise habit.
Side effects
More frequent in the CagriSema combination than either drug alone
- Eat smaller, slower meals; choose bland lower-fat foods during escalation; avoid lying down soon after eating.Seek help: Contact your prescriber if nausea is severe, persistent, or prevents eating and drinking.
Reported
- Increase fluids, fibre-rich foods, and gentle movement; consider pharmacist advice for a short-term stool softener if needed.Seek help: Contact a clinician for severe abdominal pain, no bowel movement for several days, or vomiting with constipation.
Reported
- Prioritise fluids and electrolytes; avoid alcohol, greasy meals, and very high-sugar drinks until symptoms settle.Seek help: Seek help if diarrhoea is severe, bloody, accompanied by fever, or causes dehydration.
Reported; more frequent in combination arm
- Pause solid food briefly, sip fluids, and restart bland foods once settled; do not escalate dose while vomiting persists.Seek help: Seek urgent advice for repeated vomiting, dehydration, or inability to keep fluids down.
Lifecycle factors
This is an investigational medicine
Cagrilintide is not commercially available. If you are reading this because you are participating in a trial, all questions about dose, protocol, and tolerability management should go to your trial site team — not a community forum.
CagriSema GI burden is higher than either drug alone
In Phase 2 data, the combination of cagrilintide and semaglutide produced more GI adverse events than either drug alone, though most were mild-to-moderate. Dose escalation is typically slower to minimise this.
Manage nausea with simple, bland foods
If nausea hits, reach for foods that are gentle on the stomach: plain crackers, dry toast, banana, or plain white rice. Avoid skipping meals entirely when nauseous — an empty stomach can actually make nausea worse. Cold or room-temperature foods are often better tolerated than hot, strongly-smelling dishes.
Keep a simple weekly log to share with your prescriber
A brief weekly note — covering your weight, any side effects, energy levels, and how you're eating — gives your prescriber valuable information to support and adjust your plan. It doesn't need to be detailed: even a note in your phone with a few dot points each week is enough. This log is also a powerful motivator when you look back and see how far you've come.
Important note
This content is intended for therapeutic educational purposes only and does not constitute medical advice, diagnosis, or treatment. All information presented is based on published clinical trial data. Always follow your prescriber's instructions.
Nutrition & practical guidance
Food, hydration, and adherence tips compiled from trial data and clinical companion content.
Food and hydration
✅ Prefer
⚠️ Limit
❌ Avoid
Adherence tips
Rotate your injection sites consistently
Inject into the fatty tissue of your abdomen, thigh, or upper arm — and rotate sites each week to avoid lumps or skin changes at any one spot. Keep a simple note on your phone or a sticky note to track where you injected last. Always follow your prescriber's instructions on exactly how and where to inject.
Let your injection reach room temperature first
Take your cagrilintide out of the fridge **15–30 minutes before** injecting. A cold injection can sting more and feel uncomfortable going in. Keep it out of direct sunlight while it warms up, and never try to heat it in a microwave or hot water.
Pick a weekly injection day and stick to it
Choosing the same day each week — for example, every Sunday morning — makes it much easier to build the habit and reduces the chance of missing a dose. Set a recurring phone reminder with a label like 'Weekly injection day' so it becomes a non-negotiable part of your routine.
Plan lighter meals around your injection day
Many people find that nausea is most noticeable in the 24–48 hours after their injection. Try to schedule your injection day when you can eat gently — think plain rice, scrambled eggs, or yoghurt — rather than on a day with a big social meal or celebration planned.
Protein intake supports the lean mass you want to preserve
Significant weight loss from any GLP-1 class drug can include lean mass loss. Adequate protein (1.2–1.6 g/kg/day) and resistance exercise help preserve it.
Start every morning with a full glass of water
Before coffee, before scrolling your phone — drink a full 250–300 mL glass of water first thing in the morning. This jumpstarts your hydration for the day and can help ease morning nausea. Keep a water bottle visible on your kitchen bench as a prompt.
Sip, don't gulp — especially when nauseous
Drinking large amounts of fluid quickly can worsen nausea and bloating. Instead, aim to sip water **little and often** throughout the day — roughly 150–200 mL every 30–45 minutes. A marked water bottle or hydration app can help you track this without thinking too hard about it.
Prioritise protein at every meal
When your appetite is reduced, every bite counts — so make protein the centrepiece of your meals. Aim for at least **20–30 g of protein per meal** from sources like eggs, Greek yoghurt, tinned fish, legumes, or chicken. Protein helps protect your muscle while your body adjusts, and it keeps you feeling fuller for longer.
Eat smaller portions, more frequently
Rather than three large meals, try **4–5 smaller meals or snacks** spread across the day. This works with the medication's effect on gastric emptying rather than against it, and reduces the chance of feeling uncomfortably full or nauseous after eating. A small meal might be half a cup of rolled oats with Greek yoghurt, or two boiled eggs on wholegrain toast.
Start with short, low-intensity walks
You don't need to hit the gym hard, especially in the early weeks. A **15–20 minute walk** after dinner is a great starting point — it aids digestion, supports blood sugar management, and improves mood. Gradually build toward 30 minutes most days as your energy and comfort allow. Even a stroll around the block counts.
Add light resistance training to protect muscle
As your body loses weight, including some resistance-based movement — like bodyweight exercises, resistance bands, or light weights — helps ensure you're maintaining muscle, not just losing it. Aim for **2 sessions per week** of 20–30 minutes. You don't need a gym; exercises like wall sits, chair squats, and push-ups against a bench are a great start.
Protect your sleep — it supports your progress
Poor sleep increases hunger hormones and cravings, which can work directly against the appetite-regulating effects of the medication. Aim for **7–9 hours per night** and try to keep a consistent bedtime. If nausea is disrupting your sleep, speak with your prescriber — there may be simple strategies that can help.
Measure progress beyond the scales
The number on the scale is just one data point, and it can fluctuate significantly from day to day due to fluid, food, and other factors. Keep a simple weekly note of **non-scale victories**: better energy, improved sleep, walking further without getting puffed, or clothes fitting differently. These are real signs of progress and worth celebrating.
Be patient and compassionate with yourself in early weeks
The first four weeks can genuinely be hard — nausea, fatigue, and little visible change can feel discouraging. Remember that your body is adjusting to a new medication, and discomfort in these early weeks doesn't mean it isn't working. Reach out to your prescriber or a support person if you're struggling; you don't have to navigate this alone.
Daily companion
Practical playbooks for managing symptoms, eating around side effects, tracking what matters, and reporting back to your clinician.
Symptom playbooks
Nausea
Mild nausea
Nutrition: Eat small, frequent meals (every 2–3 hours rather than large portions), Choose bland, low-fat foods — plain crackers, toast, rice, boiled potato, Eat slowly and sit upright for at least 30 minutes after meals, Cold or room-temperature foods may be better tolerated than hot meals
Hydration: Sip fluids steadily throughout the day rather than drinking large amounts at once, Plain water, diluted cordial, or clear broth are good options, Aim for at least 1.5 L of fluids daily
Avoid: High-fat, fried, or greasy foods, Spicy or strongly flavoured foods, Large meal portions, Lying flat immediately after eating
Moderate nausea
Nutrition: Reduce meal size further — small snacks every 1–2 hours if tolerated, Prioritise easy-to-digest foods: plain rice, bananas, unsalted crackers, clear soups, Ginger-containing foods or ginger tea may help some people, Avoid cooking smells if they worsen nausea — cold foods or pre-prepared options can help
Hydration: Prioritise fluid intake above solid food if appetite is very low, Try ice chips or small sips of cold water if regular drinking triggers nausea, Oral rehydration solutions (e.g. Hydralyte) can help maintain electrolytes if vomiting occurs
Avoid: All high-fat and fried foods, Alcohol, Caffeine in excess, Strong food odours
⚠ If nausea at this level persists for more than 48 hours or prevents you from keeping fluids down, contact your trial site or prescriber.
Severe nausea
Nutrition: Focus entirely on tolerating small sips of fluid — do not force solid food, If even fluids are not tolerated, seek prompt medical attention
Hydration: Attempt to sip water, clear broth, or oral rehydration solution every few minutes, If unable to keep any fluids down for more than 4–6 hours, seek urgent medical care
Avoid: Solid food until vomiting and severe nausea resolve, Any foods or smells that worsen symptoms
⚠ Severe or persistent nausea, especially with vomiting that prevents fluid intake, requires urgent contact with your trial site or medical attention. Do not wait for your next scheduled appointment.
Constipation
Mild constipation
Nutrition: Increase dietary fibre gradually — vegetables, fruit (with skin), legumes, wholegrain bread and cereals, Prunes or kiwifruit eaten daily may support regularity, Maintain regular meal timing to support bowel rhythm
Hydration: Aim for at least 2 L of water per day — fibre works best with adequate fluid, Warm fluids in the morning (e.g. warm water with lemon) may stimulate bowel movement
Avoid: Low-fibre, highly processed foods (white bread, pastries, fast food), Inadequate fluid intake
Moderate constipation
Nutrition: Continue high-fibre foods and increase variety, Consider a fibre supplement (e.g. psyllium husk) — discuss with your trial team first, Light physical activity (a short walk) can support gut motility
Hydration: Increase fluid intake to 2–2.5 L per day, Avoid excess caffeine or alcohol, which can worsen dehydration
Avoid: Dairy in excess if it worsens constipation for you personally, Red meat-heavy meals without adequate fibre
⚠ If you have not had a bowel motion in more than 4 days, or if you have significant bloating or abdominal discomfort, contact your trial site or prescriber to discuss laxative options.
Severe constipation
Nutrition: Maintain fluid and fibre intake as tolerated, Do not increase fibre further if abdomen is significantly distended or painful — seek medical review first
Hydration: Prioritise fluid intake — at least 2 L per day, Oral rehydration solutions may help if appetite is also poor
Avoid: Straining excessively — seek medical advice rather than forcing
⚠ Severe constipation (no bowel motion for more than 5–7 days), or constipation with significant abdominal pain, bloating, nausea, or vomiting, requires prompt medical review. Contact your trial site urgently.
Appetite
Very low appetite
Nutrition: Prioritise nutrient-dense, small-volume foods: eggs, yoghurt, nut butters, avocado, cheese, legumes, Liquid nutrition (e.g. milk-based smoothies, fortified drinks) can help meet protein and energy needs when solid food is not appealing, Eat on a schedule rather than waiting for hunger cues — appetite signals may be significantly blunted
Hydration: Include calorie-containing fluids (milk, smoothies) if solid food intake is very low, Avoid filling up on water immediately before meals
Avoid: Skipping all eating for full days — some nutritional intake is important even when appetite is absent, Very low calorie intake sustained over multiple weeks without dietitian guidance
⚠ If very low appetite persists for more than 1 week and you are unable to maintain adequate nutrition, discuss this with your trial prescriber or dietitian. Unexplained, severe appetite loss warrants review.
Reduced appetite
Nutrition: Focus on protein at every eating occasion to preserve muscle mass, Choose smaller portions and eat slowly to avoid early fullness, Plan meals ahead so nutritious options are ready when you do feel able to eat
Hydration: Aim for 1.5–2 L of water or low-sugar fluids per day, Avoid drinking large amounts just before eating
Avoid: Filling up on low-nutrient foods or drinks, Relying on highly processed snacks as primary nutrition
Appetite near normal
Nutrition: Maintain a balanced, portion-appropriate eating pattern, Continue to prioritise vegetables, lean protein, wholegrains, and healthy fats
Hydration: Aim for 1.5–2 L of water per day as a baseline
Food guidance by situation
Prefer: Plain crackers or dry toast, Boiled or steamed rice, Boiled or baked potato (no butter or cream), Banana or other low-acid fruit, Clear broths or soups, Ginger tea or ginger-based foods, Cold or room-temperature foods
Limit: Dairy in large amounts, Caffeinated drinks, Carbonated beverages if they worsen bloating
Avoid: Fried, greasy, or high-fat foods, Spicy or strongly flavoured dishes, Alcohol, Large meal portions
Cagrilintide slows gastric emptying via amylin-pathway action. High-fat and high-volume meals further delay gastric emptying and are strongly associated with worsened nausea in amylin-class agents.
Prefer: High-fibre vegetables (broccoli, spinach, carrots, zucchini), Fruit with skin (apples, pears, kiwifruit), Prunes or dried apricots, Legumes (lentils, chickpeas, kidney beans), Wholegrain bread, oats, and cereals, Plenty of water throughout the day
Limit: Red meat (limit, do not avoid entirely), Refined white bread and pastries, Excess dairy
Avoid: Highly processed, low-fibre snack foods, Inadequate fluid intake alongside a high-fibre diet
Slowed gastric emptying and reduced gut motility from amylin-pathway activation increase constipation risk. Fibre and fluid work together to maintain bowel regularity.
Prefer: Nutrient-dense, small-volume foods: eggs, Greek yoghurt, nut butters, avocado, cheese, Protein-rich smoothies or fortified liquid nutrition if solid food is difficult, Small, frequent eating occasions (every 2–3 hours), Familiar, appealing foods to encourage intake
Limit: High-volume, low-nutrient foods that fill stomach without providing adequate nutrition
Avoid: Going full days without any nutritional intake, Ultra-processed, nutrient-poor snacks as the primary food source
Amylin-mediated satiety signalling via area postrema receptors can significantly suppress appetite, particularly around peak plasma concentration. Nutritional adequacy must be maintained even when hunger is absent.
Prefer: Low-fat, easy-to-digest meals for the first few days after a dose increase, Smaller portions than usual, Plain, mild-flavoured foods
Limit: Restaurant or takeaway meals with unknown fat content, Festive or celebration meals with large portions
Avoid: High-fat, fried, or very rich meals in the first 3–4 days after a dose increase, Alcohol in the first days after escalation
GI side effects are most likely to emerge or worsen in the days around a dose increase, corresponding to rising plasma concentrations of cagrilintide.
Prefer: Very small amounts of bland food if tolerated, Clear fluids or oral rehydration solution, Cold foods rather than hot
Limit: Any food that triggers or worsens nausea — individual variation applies
Avoid: Large meals, High-fat foods, Strong-smelling foods, Alcohol
Nausea risk is highest around peak plasma concentration (approximately 72–96 hours post-dose in investigational data). Dietary triggers should be minimised during this window.
What to track
Suggested check-in cadence: weekly.
How would you rate your nausea over the past 24 hours? (0 = none, 10 = worst imaginable)
scale 0 10
How would you rate your appetite today? (0 = no appetite at all, 10 = appetite completely normal for you)
scale 0 10
How would you rate your energy levels today? (0 = completely exhausted, 10 = energy completely normal for you)
scale 0 10
How much has constipation bothered you this week? (0 = not at all, 10 = severely bothersome)
scale 0 10
What is your weight today? (kg, measured in the morning before eating if possible) (kg)
decimal
Approximately how many litres of fluid have you consumed today? (L)
decimal
Did you notice any redness, swelling, itching, or pain at your injection site this week?
boolean
How many times did you vomit this week? (enter 0 if none) (episodes)
integer
How many bowel motions did you have this week? (motions)
integer
What was your fasting blood glucose this morning, if you measured it? (mmol/L — leave blank if not measured) (mmol/L)
decimal
Take this to your appointment
Medication context: Amylin analogue (investigational — cagrilintide, subcutaneous once-weekly)
Key metrics: Current dose level and weeks on treatment, Weight (kg) — trend over trial participation, Body mass index (BMI) trajectory, Reported nausea severity (0–10 scale, weekly average), Reported constipation severity (0–10 scale, weekly average), Number of vomiting episodes per week, Bowel motion frequency (motions per week), Fluid intake (L/day, self-reported), Fasting blood glucose (mmol/L, if measured), Injection-site reactions (yes/no, description if yes), Energy level (0–10 scale, weekly average), Appetite score (0–10 scale, weekly average)
Relevant symptoms: Nausea, Vomiting, Constipation, Abdominal pain or bloating, Reduced appetite / very low food intake, Fatigue or low energy, Injection-site reactions (redness, swelling, itching, pain), Dizziness or light-headedness, Rapid heartbeat, Skin or eye yellowing (jaundice)
Safety and interactions
Share this information with your prescriber for personalised care decisions.
Red-flag symptoms — seek urgent care
- Persistent vomiting preventing fluid intakeUrgent careIf you have been vomiting repeatedly and cannot keep fluids down for more than 4–6 hours, seek urgent medical care and contact your trial site. Dehydration can develop quickly.
- Severe abdominal painEmergencySudden, severe, or persistent abdominal pain — particularly if it radiates to your back — requires emergency medical attention immediately. Call 000 (Australia) or your local emergency number. Contact your trial site as soon as it is safe to do so.
- Signs of severe allergic reaction (anaphylaxis)EmergencyIf you develop difficulty breathing, swelling of the face, lips, tongue or throat, a widespread rash, or feel faint after an injection, call 000 (Australia) immediately. This may be a serious allergic reaction.
- No bowel motion for more than 5–7 days with pain or bloatingContact prescriberIf you have not had a bowel motion for 5 or more days, especially with significant abdominal pain, bloating, or nausea, contact your trial site or prescriber promptly — do not manage this alone.
- Significant injection-site reactionContact prescriberMild redness or tenderness at the injection site is common. However, if you notice increasing swelling, warmth, pus, or a reaction spreading beyond the injection site, contact your trial site for assessment.
- Unexplained rapid heart rate, dizziness, or feeling faintUrgent careIf you experience a rapid heartbeat, dizziness, or feel faint — especially alongside vomiting or poor fluid intake — seek urgent medical attention and contact your trial site.
- New or worsening yellowing of skin or eyes, dark urineUrgent careYellowing of the skin or whites of the eyes, or very dark urine, may indicate a problem with your liver. Seek prompt medical review and notify your trial site.
- Suspected or confirmed pregnancyContact prescriberIf you think you may be pregnant or have a confirmed pregnancy, contact your trial site immediately. Participation in the trial and continued dosing must be reviewed urgently by your trial prescriber.
- Severe persistent vomiting or dehydration. Repeated vomiting, inability to keep fluids down, lightheadedness or reduced urine output needs urgent assessment - trial sites monitor dehydration closely on amylin-pathway therapies.
- Severe abdominal pain. Seek urgent medical advice for severe or persistent abdominal pain, especially with vomiting or pain radiating to the back.
- Pancreatitis symptoms. Severe or persistent pain in your abdomen or back, with or without vomiting, may be a sign of pancreatitis. Contact your trial site or seek emergency care immediately if this occurs.
- Severe or persistent abdominal pain. Severe pain in your abdomen that does not ease — especially if it spreads to your back or is accompanied by vomiting — may be a sign of pancreatitis. Seek urgent medical attention immediately and inform your trial site.
- Serious allergic reaction. Swelling of the face, lips, tongue, or throat, difficulty breathing, or a widespread rash may indicate a serious allergic reaction. Seek emergency medical attention immediately.
- Severe nausea, vomiting, or dehydration. If you are unable to keep fluids down for an extended period, feel dizzy when standing, or notice a significant reduction in urination, you may be becoming dehydrated. Contact your trial site promptly.
Structured warnings
Investigational medicine
Cagrilintide is not broadly approved as a standalone medicine. Dose and eligibility depend on trial protocol.
Combination GI burden
Cagrilintide plus semaglutide can increase gastrointestinal adverse events compared with either pathway alone.
Severe persistent vomiting or dehydration
Repeated vomiting, inability to keep fluids down, lightheadedness or reduced urine output needs urgent assessment - trial sites monitor dehydration closely on amylin-pathway therapies.
Severe abdominal pain
Seek urgent medical advice for severe or persistent abdominal pain, especially with vomiting or pain radiating to the back.
Investigational medicine — not yet approved
Cagrilintide is not approved by the TGA, FDA, MHRA, or EMA and is only available through clinical trials. Do not obtain or use this medicine outside a supervised trial setting.
Investigational medicine — not approved for general use
Cagrilintide has not been approved by the TGA, FDA, MHRA, or EMA. It is available only within authorised clinical trials. Do not use outside of a supervised trial setting.
Pancreatitis symptoms
Severe or persistent pain in your abdomen or back, with or without vomiting, may be a sign of pancreatitis. Contact your trial site or seek emergency care immediately if this occurs.
Severe or persistent abdominal pain
Severe pain in your abdomen that does not ease — especially if it spreads to your back or is accompanied by vomiting — may be a sign of pancreatitis. Seek urgent medical attention immediately and inform your trial site.
Serious allergic reaction
Swelling of the face, lips, tongue, or throat, difficulty breathing, or a widespread rash may indicate a serious allergic reaction. Seek emergency medical attention immediately.
Severe nausea, vomiting, or dehydration
If you are unable to keep fluids down for an extended period, feel dizzy when standing, or notice a significant reduction in urination, you may be becoming dehydrated. Contact your trial site promptly.
Nausea and gastrointestinal effects
Nausea, vomiting, decreased appetite, and diarrhoea are the most commonly reported side effects with cagrilintide in Phase 2 trials. These effects are typically mild-to-moderate and tend to improve over time, particularly with gradual dose escalation.
Use in pregnancy and breastfeeding
Cagrilintide has not been studied in pregnant or breastfeeding individuals. Clinical trials have excluded these groups. Discuss any plans for pregnancy with your trial site before continuing participation.
Use during pregnancy or breastfeeding
Cagrilintide trials have excluded people who are pregnant or breastfeeding. If you become pregnant or begin breastfeeding during the trial, notify your prescriber and trial site without delay.
Kidney and liver impairment
Phase 2 trials excluded participants with severe kidney or liver impairment. The safety profile in these populations has not been characterised. Inform your trial site of any changes to your kidney or liver health.
Injection-site reactions
Redness, swelling, bruising, or discomfort at the injection site have been reported. Rotating your injection site each week can help reduce these reactions.
Indication and approval status
Weight management and CagriSema combination use remain under clinical investigation.
Clinical trial participants only; no standalone approved prescribing population.
Who should not take this
Cagrilintide is investigational — not yet approved by the TGA, FDA, MHRA, or EMA. Access is limited to clinical trials. Based on Phase 2 trial exclusion criteria and the amylin receptor class: • Existing amylin-pathway contraindications are not fully characterised • Trials have excluded participants with severe GI disease, active eating disorders, severe kidney or liver impairment, recent cardiovascular events, pregnancy, and breastfeeding No formal prescribing label exists. Speak with your trial site or prescriber for any questions about eligibility.
Known interactions
- Insulin and insulin secretagoguessignificant
Amylin analogues can increase hypoglycaemia risk when combined with insulin-stimulating agents.
- GLP-1 receptor agonists (e.g. semaglutide in CagriSema combination)moderate
The CagriSema combination is the primary clinical context for cagrilintide use. GI adverse events were more frequent in combination than either agent alone.
- Oral medicines with narrow therapeutic indexmoderate
Additive gastric-emptying slowing from amylin + GLP-1 dual mechanisms may alter absorption of orally administered drugs.
Missed-dose guidance
No approved standalone missed-dose rule exists for cagrilintide.
Follow trial-site instructions and do not self-adjust the schedule.
If your weekly injection is overdue by up to 3 days (72 hours), administer it as soon as you remember, then resume your usual weekly schedule from that new day. If more than 3 days have passed since your scheduled dose, contact your trial site before administering the injection.
Always follow the specific guidance provided by your trial site; missed-dose rules may differ between trial protocols. Do not administer two doses within the same week.
If your weekly injection is missed, administer it as soon as you remember — provided your next scheduled dose is at least 72 hours (3 days) away. If fewer than 72 hours remain until your next scheduled dose, omit the missed dose and resume on your usual day.
Resume your regular once-weekly schedule from the next planned injection day. Do not administer two doses within 72 hours of each other. Contact your trial site if you are unsure what to do.
When to seek help
Nausea that is severe, persistent, or worsens after combination escalation.
Contact the trial site or prescriber before escalating.
Repeated vomiting or inability to maintain hydration.
Seek medical advice promptly.
Side-effect timing windows
Population typicals from trial data — individual experience varies.
Nausea
Onset 1–24 h · Peak 24–72 h · Resolves ~14d
Amylin-pathway nausea typically settles faster than GLP-1 nausea once tolerated.
Vomiting
Onset 2–24 h · Peak 24–72 h · Resolves ~7d
Trial data.
Decreased appetite
Onset 1–72 h · Peak 24–96 h · Resolves ~4d
Consistent with amylin receptor-mediated satiety signalling. Expected pharmacodynamic effect observed across Phase 2 cohorts; may be sustained across the dosing week.
Diarrhoea
Onset 2–48 h · Peak 12–72 h · Resolves ~3d
Reported in Phase 2 trials; generally mild. Maintain adequate fluid intake. Contact your trial site if persistent or severe.
Injection-site reaction
Onset 0.5–24 h · Peak 1–48 h · Resolves ~3d
Localised redness, swelling, or discomfort at the injection site. Typically resolves within a few days. Consistent site rotation helps minimise recurrence.
Constipation
Onset 24–96 h · Peak 48–168 h · Resolves ~5d
Consistent with amylin-class slowing of gastrointestinal motility and gastric emptying. Adequate hydration and dietary fibre are recommended.
Approved injection sites
Abdomen
Trial protocol rotates weekly across abdomen, thigh and upper arm; follow trial-site instruction.
Avoid: Investigational use only.
Thigh
Front of the thigh.
Upper arm
The outer aspect of the upper arm may be used, typically with assistance from another person to ensure correct technique.
Avoid: Self-injection into the upper arm can be technically difficult; seek guidance from your trial site nurse if using this site.
Structured storage
investigational injection
trial supplied
Follow trial protocol
Storage requirements are protocol- and formulation-specific until an approved product label exists.
Storage and handling
As an investigational biologic, storage specifics are governed by the trial protocol or supplying pharmacy. Amylin analogues in this class are expected to require refrigeration at 2–8°C (36–46°F). Freezing typically destroys peptide biologics. Always follow the storage instructions provided by your trial site.
Research evidence
Published studies, labels, regulator pages, and curated protocol sources connected to this profile.
API source references
Cagrilintide Phase 2 dose-finding trial
Enebo LB et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of cagrilintide in people with overweight or obesity. Lancet. 2021.
Open source ↗CagriSema Phase 2 trial
Frias JP et al. Cagrilintide plus semaglutide in type 2 diabetes. Lancet. 2023.
Open source ↗Safety, tolerability, pharmacokinetics, and pharmacodynamics of cagrilintide 4.5 mg with semaglutide 2.4 mg (CagriSema) in adults with overweight or obesity: a randomised, controlled, phase 1b trial
Human trial · 2021 · The Lancet · n=96 · Adults with overweight or obesity (BMI 27–39.9) without type 2 diabetes
96 adults were randomised to once-weekly cagrilintide 4.5 mg alone, semaglutide 2.4 mg alone, CagriSema combination, or placebo for 20 weeks. Mean body-weight change was −15.6% with CagriSema versus −8.8% with semaglutide alone and −8.7% with cagrilintide alone — suggesting additive effects of the combination.
Reported outcomes
- weight_loss: Additive weight loss suggests complementary mechanisms — amylin and GLP-1 pathways appear to act synergistically. (Secondary)
- weight_loss: Mean body-weight change of −15.6% with CagriSema versus −8.8% with semaglutide alone and −8.7% with cagrilintide alone at 20 weeks. (Primary outcome)
Reported dosage
- 4.5 mg · once weekly subcutaneous · 20 weeks — Combined with semaglutide 2.4 mg in the CagriSema arm of the Phase 1b trial.
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