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Cagrilintide research

What published studies found for Cagrilintide: 7 papers, 7 in humans, with sample sizes and key results, plus 40 registered clinical trials.

Strong human evidence

Why: Phase 3 RCTs (thousands) show adding it to semaglutide boosts weight loss over semaglutide alone; a 706-person phase 2 RCT of cagrilintide alone also beat placebo.

Cagrilintide (a long-acting amylin analogue) is mainly studied in combination with semaglutide (CagriSema), where several large phase 3 human RCTs show about 13-20% weight loss at 68 weeks and better glucose control than semaglutide alone; evidence for cagrilintide on its own comes from a phase 2 trial and comparator arms showing more modest weight loss (roughly 6-11%). Gastrointestinal side effects are very common.

✓ 6 positive~ 1 mixed

Most high-quality data concern the cagrilintide-semaglutide combination rather than cagrilintide alone.

US compounding: Not compoundable. Not an FDA-approved drug and not nominated for FDA's 503A bulks list, so US pharmacies can't legally compound it. Status for every peptide.

Browse and filter these papers Cagrilintide prices and vendors

Reported side effects

commonGastrointestinal events (nausea, vomiting, diarrhea, constipation, abdominal pain), mostly transient and mild-moderate [ref] [ref] [ref] [ref]
commonVomiting (higher with the combination than semaglutide alone) [ref]
reportedInjection/administration-site reactions [ref]
uncommonDiscontinuation due to adverse events [ref]

Registered clinical trials

40 trials of Cagrilintide on ClinicalTrials.gov: 16 active, 24 completed, 1 with posted results. Registered trials include ones that haven't published yet.

Trial	Status	Phase	People	Sponsor
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood VesselsNCT05669755 · started 2023-03-01	Active, not recruiting	Phase 3	7,101	Novo Nordisk A/S
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose WeightNCT05567796 · started 2022-11-01	Active, not recruiting	Phase 3	3,400	Novo Nordisk A/S
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-termNCT07011667 · started 2025-06-03	Active, not recruiting	Phase 3	609	Novo Nordisk A/S
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body WeightNCT07253285 · started 2026-01-08	Recruiting	Phase 3	460	Novo Nordisk A/S
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With ObesityNCT06780449 · started 2025-02-10	Active, not recruiting	Phase 3	400	Novo Nordisk A/S
Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With CagrilintideNCT07220759 · started 2025-11-05	Active, not recruiting	Phase 3	330	Novo Nordisk A/S
Weight Loss in People Living With Overweight or Obesity Following Treatment With CagrilintideNCT07220642 · started 2025-11-05	Active, not recruiting	Phase 3	300	Novo Nordisk A/S
A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body WeightNCT07745504 · started 2026-08-04	Recruiting	Phase 3	285	Novo Nordisk A/S
A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or ObesityNCT07597018 · started 2026-05-18	Recruiting	Phase 1	234	Novo Nordisk A/S
The Role of the Amylin Analogue Cagrilintide in Bone MetabolismNCT07010432 · started 2025-06-12	Recruiting	Phase 1	144	Novo Nordisk A/S
A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or ObesityNCT07557953 · started 2026-04-30	Recruiting	Phase 1	120	Novo Nordisk A/S
Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse EventsNCT07607587 · started 2026-05-29	Recruiting	Phase 1	114	Novo Nordisk A/S

All 40 Cagrilintide trials, with countries and recruiting status

Meta-analyses & systematic reviews

✓ Positivemeta-analysisJ Diabetes Metab Disord · 2026

Cagrilintide and CagriSema for weight reduction and metabolic risk modification in overweight or obesity: a systematic review and meta-analysis.

n = 5,023 humansSystematic review and random-effects meta-analysis (PRISMA 2020, AMSTAR 2, Cochrane RoB 2)

Pooling 4 trials (5,023 participants), cagrilintide alone reduced weight by 6.08% vs placebo and CagriSema by 5.98% (pooled estimate); adverse events were more frequent but discontinuation rates were similar to placebo.

Key resultPercent body weight change vs placebo: cagrilintide MD -6.08% (95% CI -8.02 to -4.14); CagriSema -5.98% (95% CI -10.64 to -1.32)

Studied: Adults with overweight or obesity in RCTs of cagrilintide or CagriSema vs placebo
Compared with: Placebo
Main outcome: Percent change in body weight
Sample: 4 trials, 5,023 participants pooled
Authors' conclusion: Cagrilintide and CagriSema achieved clinically meaningful weight loss with favorable cardiometabolic effects and acceptable tolerability.
Limitations: Only four trials pooled; adverse events more frequent with active treatment.

PubMed 42180166 DOI Free full text

✓ Positivemeta-analysisIndian J Endocrinol Metab · 2024

Efficacy and Safety of Cagrilintide Alone and in Combination with Semaglutide (Cagrisema) as Anti-Obesity Medications: A Systematic Review and Meta-Analysis.

n = 430 humansSystematic review and meta-analysis of RCTs20-32 weeks

Pooling 3 RCTs (430 people), CagriSema gave about 9% more weight loss than semaglutide alone, with more GI events and vomiting; cagrilintide alone was similar to semaglutide/liraglutide with less vomiting.

Key resultCagriSema vs semaglutide 2.4 mg: percentage weight loss MD -9.07% (95%CI -11.91, -6.23; P < 0.00001; I2 = 96%)

Studied: Obese individuals in RCTs of cagrilintide or CagriSema
Compared with: Placebo or active comparator (semaglutide, liraglutide)
Main outcome: Change in body weight; glycemia, lipids, adverse events
Sample: 3 RCTs, 430 individuals (from 678 articles)
Authors' conclusion: CagriSema outperforms semaglutide for weight loss; cagrilintide shows comparable weight loss to semaglutide/liraglutide with significantly lower vomiting.
Limitations: Only 3 RCTs; very high heterogeneity (I2 96-98%).

PubMed 39676787 DOI Free full text

Human studies

✓ Positivehuman RCTN Engl J Med · 2025

Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity.

n = 3,417 humansPhase 3a multicenter, double-blind, placebo- and active-controlled trial (REDEFINE 1)68 weeks

In 3417 adults with overweight/obesity without diabetes (REDEFINE 1), cagrilintide plus semaglutide reduced weight by 20.4% at 68 weeks vs 3.0% with placebo; GI adverse events 79.6% vs 39.9%.

Key resultMean body-weight change -20.4% with cagrilintide-semaglutide vs -3.0% with placebo (difference -17.3 percentage points, 95% CI -18.1 to -16.6; P<0.001)

Studied: Adults without diabetes with BMI of 30 or higher, or 27 or higher with at least one obesity-related complication
Compared with: Placebo (also semaglutide alone and cagrilintide alone), plus lifestyle interventions
Main outcome: Relative change in body weight and reduction of 5% or more at week 68
Sample: 3417 randomized 21:3:3:7 (2108 CagriSema, 302 semaglutide, 302 cagrilintide, 705 placebo)
Authors' conclusion: Cagrilintide-semaglutide provided significant and clinically relevant body-weight reductions compared with placebo; GI adverse events were mainly transient and mild-to-moderate.
Limitations: Funded by Novo Nordisk; GI adverse events 79.6% vs 39.9% with placebo.

PubMed 40544433 DOI

✓ Positivehuman RCTLancet Diabetes Endocrinol · 2026

Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study.

n = 2,713 humansRandomised, double-blind, placebo- and active-controlled phase 3 trial in 30 countries (REIMAGINE 2)68 weeks

In 2713 people with type 2 diabetes, the combination lowered HbA1c slightly more than semaglutide 2.4 mg alone (-1.91 vs -1.75 points) over 68 weeks; adverse events 86.9% vs 70.5% on placebo, mostly GI.

Key resultHbA1c change -1.91 vs -1.75 percentage points; estimated treatment difference -0.16 (95% CI -0.27 to -0.05; p=0.0035)

Studied: Adults with inadequately controlled type 2 diabetes on metformin (with or without SGLT2 inhibitor) and BMI of 25 or more
Compared with: Semaglutide 2.4 mg (primary), cagrilintide, lower-dose combination, placebo
Main outcome: Change in HbA1c at week 68, CagriSema 2.4 mg each vs semaglutide 2.4 mg
Sample: 2713 randomly assigned across six groups
Authors' conclusion: Cagrilintide-semaglutide (2.4 mg each) was superior to semaglutide 2.4 mg in reducing HbA1c; safety was consistent with the GLP-1 receptor agonist class and prior cagrilintide data.
Limitations: Funded by Novo Nordisk; efficacy-estimand primary result.

PubMed 42251859 DOI

✓ Positivehuman RCTN Engl J Med · 2025

Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes.

n = 1,206 humansPhase 3a double-blind randomized placebo-controlled trial in 12 countries (REDEFINE 2)68 weeks

In 1206 adults with obesity and type 2 diabetes (REDEFINE 2), the combination reduced weight by 13.7% vs 3.4% with placebo; GI adverse events 72.5% vs 34.4%.

Key resultWeight change -13.7% vs -3.4% with placebo (difference -10.4 percentage points, 95% CI -11.2 to -9.5; P<0.001)

Studied: Adults with BMI of 27 or more and type 2 diabetes (HbA1c 7 to 10%)
Compared with: Placebo plus lifestyle intervention
Main outcome: Percent change in body weight; proportion with weight reduction of 5% or more
Sample: 1206 randomized 3:1 (904 CagriSema, 302 placebo)
Authors' conclusion: Once-weekly cagrilintide-semaglutide (2.4 mg each) resulted in significantly lower body weight than placebo in adults with obesity and type 2 diabetes.
Limitations: Funded by Novo Nordisk; GI adverse events 72.5% vs 34.4%.

PubMed 40544432 DOI

~ Mixedhuman RCTLancet · 2023

Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial.

n = 92 humansMulticentre, randomised, double-blind, active-controlled phase 2 trial at 17 US sites32 weeks

In 92 people with type 2 diabetes, CagriSema gave more weight loss (-15.6%) than semaglutide (-5.1%) or cagrilintide (-8.1%) at 32 weeks, but its HbA1c reduction was not significantly greater than semaglutide alone.

Key resultHbA1c change -2.2 (CagriSema) vs -1.8 (semaglutide) vs -0.9 (cagrilintide) percentage points; vs cagrilintide p<0.0001, vs semaglutide p=0.075

Studied: Adults with type 2 diabetes, BMI 27 or higher, on metformin with or without SGLT2 inhibitor
Compared with: Semaglutide 2.4 mg and cagrilintide 2.4 mg
Main outcome: Change in HbA1c from baseline
Sample: 92 randomized (31 CagriSema, 31 semaglutide, 30 cagrilintide)
Authors' conclusion: CagriSema improved glycaemic control and weight loss and was well tolerated; HbA1c improvement was greater than cagrilintide but not significantly greater than semaglutide.
Limitations: Small phase 2 trial (92 participants); HbA1c not superior to semaglutide.

PubMed 37364590 DOI

✓ Positivehuman RCTLancet · 2021

Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial.

706 to cagrilintide 0.3-4.5 mg (100-102 per dose), 99 liraglutide, 101 placeboMulticentre, randomised, double-blind, placebo- and active-controlled dose-finding phase 2 trial at 57 sites26 weeks treatment plus 6 weeks follow-up

In 706 adults with overweight/obesity, 26 weeks of cagrilintide alone reduced weight by 6.0-10.8% vs 3.0% with placebo; nausea in 20-47% vs 18%.

Key resultWeight reductions 6.0%-10.8% across cagrilintide doses vs 3.0% with placebo (p<0.001); 4.5 mg vs liraglutide 10.8% vs 9.0% (p=0.03)

Studied: Adults without diabetes with BMI of at least 30, or at least 27 with hypertension or dyslipidaemia
Compared with: Placebo and liraglutide 3.0 mg daily
Main outcome: Percentage change in bodyweight at week 26
Authors' conclusion: Cagrilintide led to significant bodyweight reductions in people with overweight and obesity and was well tolerated, supporting development of novel mechanism molecules.
Limitations: Funded by Novo Nordisk; GI adverse events more common (41%-63% vs 32% placebo).

PubMed 34798060 DOI

Verdicts are judged on each paper's own main outcome; grades run from A (strong human evidence) to D (little or none). Details are read from the abstracts, and figures are reproduced only from openly licensed full texts. Not medical advice.