Cagrilintide: research

An unapproved weekly amylin analogue with weight-loss trials and common stomach symptoms.

Also called: AM833, NNC0174-0833, NN9838, Cagri.

Amylin analogues · Long-acting amylin analogue; amylin and calcitonin receptor agonist.

27 unique registered studies with cagrilintide-alone or comparator arms; includes ongoing/unreported trials. Reviews and animal studies are not counted.

Studies

• First human single-dose study. rct, n=54, Age 22 Years to 64 Years; Metabolism and Nutrition Disorder; Obesity. Status: completed. No clinical benefit is established by registration. (source)
• First repeat-dose study. rct, n=96, Age 22 Years to 55 Years; Metabolism and Nutrition Disorder; Obesity. Status: completed. No clinical benefit is established by registration. (source)
• Japanese and White adults: PK. rct, n=66, Age not specified; Obesity; Overweight. Status: completed. No clinical benefit is established by registration. (source)
• Phase 2: five weekly doses. rct, n=706, Adults with obesity or overweight with hypertension/dyslipidemia; no diabetes. All five cagrilintide doses reduced weight more than placebo. (source)
• Birth-control pill interaction. crossover-rct, n=31, Age 18 Years to 65 Years; Overweight; Obesity. Status: completed. No clinical benefit is established by registration. (source)
• Single dose: kidney impairment. pk-study, n=33, Normal kidney function or mild, moderate or severe kidney impairment. A single dose showed no clinically relevant kidney-related exposure change. (source)
• Phase 2: combination versus each drug. rct, n=92, Adults with type 2 diabetes and BMI ≥27 on metformin, with or without an SGLT2 inhibitor. The combination added weight loss; its HbA1c advantage over semaglutide was not significant. (source)
• Chinese adults: single-dose PK. rct, n=24, Age 18 Years to 55 Years; Overweight and Obesity. Status: completed. No clinical benefit is established by registration. (source)
• Single dose: liver impairment. pk-study, n=32, Normal liver function or mild, moderate or severe liver impairment. A single dose showed no clinically relevant liver-related exposure change. (source)
• REDEFINE 1: obesity without diabetes. rct, n=3417, Adults without diabetes: BMI ≥30, or ≥27 with a weight-related condition. The combination reduced weight more than placebo; its components also had separate arms. (source)
• Heart-rhythm safety: 4.5 mg. rct, n=105, Healthy adults; 105 exposed of 107 enrolled. No clinically relevant QT prolongation was detected. (source)
• REIMAGINE 2: seven randomized arms. rct, n=2713, Adults with type 2 diabetes on metformin with or without an SGLT2 inhibitor. The higher combination dose added a small HbA1c reduction versus semaglutide. (source)
• Kidney disease and albumin leakage. rct, n=626, Age 18 Years; Chronic Kidney Disease; Type 2 Diabetes; Obesity. Status: completed. No clinical benefit is established by registration. (source)
• Insulin sensitivity study. rct, n=158, Age 18 Years to 75 Years; Diabetes Mellitus, Type 2. Status: completed. No clinical benefit is established by registration. (source)
• Alcohol-related liver disease. rct, n=270, Age 18 Years; Alcohol-related Liver Disease. Status: completed. No clinical benefit is established by registration. (source)
• New amylin drug: cagrilintide comparator. rct, n=178, Age 18 Years to 55 Years; Obesity; Overweight. Status: completed. No clinical benefit is established by registration. (source)
• RAMBO: bone metabolism. rct, n=144, Age 50 Years to 70 Years; Obesity. Status: recruiting. No clinical benefit is established by registration. (source)
• RENEW 1: obesity. rct, n=300, Age 18 Years; Obesity; Overweight. Status: active not recruiting. No clinical benefit is established by registration. (source)
• RENEW 2: diabetes. rct, n=330, Age 18 Years; Overweight; Obesity; Type 2 Diabetes. Status: active not recruiting. No clinical benefit is established by registration. (source)
• Youth obesity study. rct, n=460, Age 8 Years to 18 Years; Overweight; Obesity. Status: recruiting. No clinical benefit is established by registration. (source)
• GIP with cagrilintide: tolerability. crossover-rct, n=100, Age 18 Years to 64 Years; Overweight; Obese. Status: recruiting. No clinical benefit is established by registration. (source)
• RASMUS: muscle health. rct, n=100, Age 50 Years to 70 Years; Obesity. Status: recruiting. No clinical benefit is established by registration. (source)
• Cagrilintide and food intake. rct, n=120, Age 18 Years to 64 Years; Overweight; Obesity. Status: recruiting. No clinical benefit is established by registration. (source)
• Repeat-dose cagrilintide formulations. rct, n=234, Age 18 Years to 64 Years; Obesity; Overweight. Status: recruiting. No clinical benefit is established by registration. (source)
• Two cagrilintide formulations: PK. rct, n=50, Age 18 Years to 64 Years; Overweight; Obesity. Status: completed. No clinical benefit is established by registration. (source)
• Prior GLP-1 intolerance. rct, n=114, Age 18 Years; Obesity; Overweight. Status: recruiting. No clinical benefit is established by registration. (source)
• RENEW 4: injection devices. rct, n=285, Age 18 Years; Overweight; Obesity. Status: recruiting. No clinical benefit is established by registration. (source)
• Meta-analysis: versus semaglutide. meta-analysis, n=3545, Three randomized trials in adults with obesity. Combination weight loss was greater; monotherapy safety needs further study. (source)
• Receptor pharmacology. in-vitro, Receptor-expressing cells. Cagrilintide activates amylin and calcitonin-family receptors. (source)
• Brain amylin receptor mechanism. animal, Wild-type and RAMP1/3 knockout mice. Brain amylin receptors 1 and 3 contributed to weight effects in mice. (source)
• Cagrilintide plus retatrutide: rats. animal, Male rats with obesity. A rat combination study reported added weight and metabolic effects. (source)
• Phase 2: posted observed results. rct, n=706, Same participants as the phase 2 dose-finding paper. Posted observed means differ from the paper’s model-based estimates. (source)
• Phase 2 diabetes: posted results. rct, n=92, Same phase 2 diabetes participants; counts use observed/evaluable data. Observed registry results are shown separately from the paper’s estimated treatment effects. (source)
• REIMAGINE 2: full primary sponsor table. rct, n=2713, Same REIMAGINE 2 participants; not an additional trial. The primary sponsor table reports all active and pooled placebo results. (source)

Gaps: No approved label or independently verified clinician-published cagrilintide dosing protocol was found. Many early PK and formulation studies have no posted outcomes or public numeric dose steps. The highest verified published weekly target is 4.5 mg; undisclosed ongoing doses cannot define a higher ceiling. No validated home-vial storage, reconstitution, acid adjustment or shelf life was found. Long-term cardiovascular, pregnancy, infant and rare-harm evidence remains incomplete. Community prevalence labels describe this convenience sample; no population-use rate was measured. A complete, proven cycling or receptor-reset schedule was not found. Exact 503A nomination history and any cagrilintide-specific PCAC decision remain unresolved.

Related to Cagrilintide

• CagriSema: An unapproved cagrilintide–semaglutide combination with phase 3 weight-loss and diabetes results.
• Pramlintide: A diabetes medicine that copies a hormone released with insulin; Symlin products are discontinued.
• Semaglutide: A GLP-1 medicine with strong weight, glucose, heart and kidney evidence; dose and formulation matter.
• Tirzepatide: A weekly GIP/GLP-1 injection with strong diabetes and weight-loss evidence and common stomach side effects.
• Retatrutide: An experimental weekly injection with phase 3 weight-loss results.

Cagrilintide: the short version

Sources

• 503B Bulk Drug Substances List, FDA · FDA · 2026
• The Prohibited List, World Anti-Doping Agency · World Anti-Doping Agency · 2026
• Nutritional priorities to support GLP-1 therapy for obesity: a joint Advisory from the American College of Lifestyle Medicine, the American Society for Nutrition, the Obesity Medicine Association, and The Obesity Society., Mozaffarian D et al. · The American journal of clinical nutrition · 2025
• Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act
• Chest pain, NHS
• European Medicines Agency decision P/0307/2023 of 4 August 2023 on the granting of a product specific waiver for cagrilintide / semaglutide (EMEA-003059-PIP02-23)
• FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, US Food and Drug Administration
• PIP Search Page, MHRA
• SYMLINPEN- pramlintide acetate injection
• Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026
• Understanding your responsibilities when importing, compounding and supplying unapproved peptide products
• Vision loss, NHS
• Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study., Buse JB et al. · The lancet. Diabetes & endocrinology · 2026
• Efficacy and Safety of Cagrilintide and Cagrisema Versus Semaglutide as Anti-Obesity Medications: A Systematic Review, Meta-Analysis and Meta-Regression., Ahmed M et al. · Diabetes, obesity & metabolism · 2026
• Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide., Nielsen MJF et al. · Clinical pharmacokinetics · 2026

Sources checked: 2026-10-18.

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