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Cag5.0
Cagrilintide Research
Mostly mechanism / observationalLimited safety
10 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Cagrilintide studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from medium-quality meta-analyses and randomised trials published 2021–2025 with a typical study size of 706 participants.
Based on 10 studies · 2 meta-analyses · 6 RCTs · 5,621 total participants
Confidence
High
By outcome
Weight management
Mostly mechanism / observational9 studies
Safety profile
Mostly mechanism / observational7 studies
Glucose & glycemic control
Mostly mechanism / observational3 studies
Active research area
10 studies in the last 5 years · Latest meta-analysis: 2024
20212025
1RCTn=3,417 · very large study2025
The estimated mean percent change in body weight from baseline to week 68 was -20.4% with cagrilintide-semaglutide as compared with -3.0% with placebo (estimated difference, -17.3 percentage points...).
Garvey WT, Blüher M, Osorto Contreras CK, Davies MJ, Winning Lehmann E, Pietiläinen KH, Rubino D, Sbraccia P, Wadden T, Zeuthen N, Wilding JPH. · N Engl J Med (2025)
Pivotal phase-3a (REDEFINE 1), 68-week, double-blind, placebo- and active-controlled trial in 3,417 adults without diabetes (BMI >=30, or >=27 with a complication); CagriSema vs semaglutide alone vs cagrilintide alone vs placebo (all 2.4 mg)
CagriSema produced -20.4% mean weight loss vs -3.0% placebo at week 68 (difference -17.3 percentage points); also superior to semaglutide and cagrilintide monotherapy arms
Includes a 302-participant cagrilintide-monotherapy arm — the largest standalone-cagrilintide dataset to date
The estimated mean change in body weight from baseline to week 68 was -13.7% in the cagrilintide-semaglutide group and -3.4% in the placebo group (estimated difference, -10.4 percentage points...).
Davies MJ, Bajaj HS, Broholm C, Eliasen A, Garvey WT, le Roux CW, Lingvay I, Lyndgaard CB, Rosenstock J, Pedersen SD. · N Engl J Med (2025)
Pivotal phase-3a (REDEFINE 2), 68-week, double-blind, placebo-controlled trial in 1,206 adults with overweight/obesity and type 2 diabetes (BMI >=27, HbA1c 7-10%); once-weekly CagriSema 2.4 mg each vs placebo
CagriSema produced -13.7% mean weight loss vs -3.4% placebo at week 68 (difference -10.4 percentage points)
73.5% of the CagriSema group reached HbA1c <=6.5% vs 15.9% placebo
Mean percentage weight reductions from baseline were greater with all doses of cagrilintide (0·3-4·5 mg, 6·0%-10·8%) versus placebo (3·0%)... Weight reductions were also greater with cagrilintide 4·5 mg versus liraglutide 3·0 mg (10·8% vs 9·0%).
Lau DCW, Erichsen L, Francisco AM, Satylganova A, le Roux CW, McGowan B, Pedersen SD, Pietiläinen KH, Rubino D, Batterham RL. · Lancet (2021)
Phase-2, double-blind, randomised, placebo- and active-controlled dose-finding trial across 57 sites in ten countries; 706 adults with overweight/obesity (no diabetes) on once-weekly subcutaneous cagrilintide 0.3-4.5 mg vs liraglutide 3.0 mg vs placebo over 26 weeks
Mean weight loss ranged 6.0-10.8% across cagrilintide doses vs 3.0% placebo; the 4.5 mg dose modestly beat liraglutide 3 mg (10.8% vs 9.0%)
Gastrointestinal disorders (nausea, constipation, diarrhoea) and administration-site reactions were the most frequent adverse events; GI events 41-63% across doses vs 32% placebo
The mean change in bodyweight from baseline to week 32 (CagriSema: -15·6%; semaglutide: -5·1%; cagrilintide: -8·1%) was greater with CagriSema versus both semaglutide and cagrilintide.
Phase-2, double-blind, active-controlled trial in 92 adults with type 2 diabetes on metformin ± SGLT2 inhibitor; once-weekly CagriSema vs semaglutide vs cagrilintide (all escalated to 2.4 mg) over 32 weeks
Cagrilintide monotherapy lowered weight and HbA1c less than the combination; mild/moderate GI events were most common, with no level 2-3 hypoglycaemia and no fatal events
At week 20, mean percentage bodyweight reductions were greater with cagrilintide 1·2 and 2·4 mg than with placebo (15·7% for cagrilintide 1·2 mg and 17·1% for cagrilintide 2·4 mg vs 9·8% for pooled placebo)... all in combination with semaglutide 2·4 mg.
Enebo LB, Berthelsen KK, Kankam M, Lund MT, Rubino DM, Satylganova A, Lau DCW. · Lancet (2021)
Phase-1b, randomised, placebo-controlled, multiple-ascending-dose trial in 95 treated adults with overweight/obesity; once-weekly subcutaneous cagrilintide 0.16-4.5 mg co-administered with semaglutide 2.4 mg over 20 weeks
Proof of concept for the CagriSema combination: ~15-17% weight loss at the 1.2/2.4 mg doses vs ~9.8% pooled placebo (all with semaglutide)
Cagrilintide half-life 159-195 h; exposure proportional to dose and did not affect semaglutide exposure; 37% of adverse events were GI disorders, most mild-to-moderate
Cagrilintide did not result in clinically relevant QTcF prolongation, indicating no increased risk of ventricular tachyarrhythmias.
Gabe MBN, Fuhr R, Sinn A, Eliasen A, Berthelsen KK, Kuhlman AB, Bækdal TA, Nejad AB. · Diabetes Obes Metab (2024)
Double-blind thorough-QT study in 105 healthy participants randomised to once-weekly subcutaneous cagrilintide escalated to 4.5 mg or placebo, with oral moxifloxacin as a positive control
No clinically relevant QTcF prolongation after the 4.5 mg dose — upper 90% CI limits below 10 ms at all timepoints
QT assay sensitivity confirmed via moxifloxacin positive control
Cagrisema outperforms semaglutide regarding weight loss. Cagrilintide shows comparable weight loss to semaglutide/liraglutide with significantly lower vomiting.
Dutta D, Nagendra L, Harish BG, Sharma M, Joshi A, Hathur B, Kamrul-Hasan A. · Indian J Endocrinol Metab (2024)
Systematic review and meta-analysis of 3 RCTs (430 individuals) of cagrilintide alone or as CagriSema vs placebo/active comparator
CagriSema gave significantly greater weight loss than semaglutide 2.4 mg (mean difference -9.07%); cagrilintide 2.4 mg alone was comparable to semaglutide/liraglutide (-1.83%, non-significant)
GI adverse events and vomiting were higher with CagriSema than semaglutide; vomiting was significantly lower with cagrilintide than semaglutide/liraglutide
We report here the development of the stable, lipidated long-acting amylin analogue cagrilintide... Cagrilintide is currently in clinical trial and has induced significant weight loss when dosed alone or in combination with the GLP-1 analogue semaglutide.
Kruse T, Hansen JL, Dahl K, Schäffer L, Sensfuss U, Poulsen C, Schlein M, Hansen AMK, Jeppesen CB, Dornonville de la Cour C, Clausen TR, Johansson E, Fulle S, Skyggebjerg RB, Raun K. · J Med Chem (2021)
Medicinal-chemistry discovery paper from Novo Nordisk describing the design of cagrilintide to overcome amylin's amyloid-fibril aggregation and short half-life
Cagrilintide was engineered as a stable, lipidated long-acting amylin analogue selected for clinical development in obesity
Notes significant weight loss when dosed alone or with semaglutide in early clinical work
Cagrilintide alone, as well as cagrilintide in combination with semaglutide have shown promising weight loss in clinical trials that supports the further development of this therapy for sustained weight management.