Weight Loss

CagriSema

Also known as: Semaglutide + Cagrilintide

Clinical Trials
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Key Facts: CagriSema

Category
Weight Loss
FDA Status
Not FDA Approved
Clinical Status
NDA Submitted (Dec 18, 2025) - FDA decision expected Q4 2026. First once-weekly combination of GLP-1 and amylin analogues for weight management.
Administration
Subcutaneous injection weekly
Typical Dose
Limited community data available
Frequency
See research protocols
Duration
Long-term use expected
Also Known As
Semaglutide + Cagrilintide

Mechanism of Action

The combination works on two different appetite systems at once. Semaglutide mimics GLP-1, a gut hormone that boosts insulin after meals, slows stomach emptying, and signals fullness to the brain. Cagrilintide is a synthetic version of amylin, a hormone co-secreted with insulin from the pancreas, which reduces food intake and reinforces satiety through separate brain circuits in the hindbrain and hypothalamus. The idea, still being characterized, is that hitting GLP-1 and amylin pathways together produces more appetite suppression than either alone. Both components are engineered for slow release so a single weekly dose maintains steady drug levels.

Research Summary

This is one of the better-tested experimental obesity drugs because it went straight into large human phase 3 trials rather than living only in animal data. In REDEFINE 1, about 3,400 adults with overweight or obesity but without diabetes were randomized over 68 weeks; CagriSema produced roughly 20.4% average body weight loss versus 14.9% for semaglutide alone, 11.5% for cagrilintide alone, and 3.0% for placebo, with results published in the New England Journal of Medicine in 2025. REDEFINE 2 tested it in adults with type 2 diabetes and also met its endpoints, showing meaningful weight loss and HbA1c improvement compared with placebo. Notably, the headline 20% figure landed below Novo Nordisk's own 25% target, which disappointed investors even though the drug clearly worked. The most common side effects were gastrointestinal: nausea, vomiting, diarrhea, and constipation, consistent with the GLP-1 plus amylin class. CagriSema is not FDA-approved as of mid-2026, so anything sold under that name outside a clinical setting is unregulated.

Trial Progress:Preclinical
Pre
I
II
III
IV
FDA

Dosing Information

Human Trials·Human studies conducted, not FDA approved

Typical Dosing

Community experience

Common Dose

Limited community data available

Range

See research dosing

Frequency

See research protocols

Research Dosing

Scientific studies

Doses from clinical trials

Doses from Studies

Semaglutide 2.4mg + Cagrilintide 2.4mg weekly

Clinical Trial Data - Phase 3 Clinical Trials

Duration

Long-term use expected

Administration

Subcutaneous injection weekly

Timing & Administration

Best Time to Take

Before bed or morning (fasted)

Follow specific peptide protocol

Food Recommendation

Take on empty stomach

Why This Timing?

GH-related peptides work best on an empty stomach to maximize growth hormone release.

Possible Side Effects

Not everyone experiences these effects. Individual responses vary based on dosage, duration, and personal factors.

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • GI events (72-80% vs 34-40% placebo)
  • Higher GI effects than semaglutide alone
  • Investigational - not yet approved

References

Research This Peptide Further

Frequently Asked Questions

What does CagriSema do?

CagriSema is a once-weekly injectable that pairs two drugs in one shot: semaglutide (a GLP-1 receptor agonist, the molecule behind Ozempic and Wegovy) and cagrilintide (a long-acting amylin analog). It is being developed by Novo Nordisk for obesity and type 2 diabetes, and in 2025 it cleared its phase 3 REDEFINE trials. It is not yet approved by the FDA, though regulatory filings are underway.

How does CagriSema work?

The combination works on two different appetite systems at once. Semaglutide mimics GLP-1, a gut hormone that boosts insulin after meals, slows stomach emptying, and signals fullness to the brain. Cagrilintide is a synthetic version of amylin, a hormone co-secreted with insulin from the pancreas, which reduces food intake and reinforces satiety through separate brain circuits in the hindbrain and hypothalamus. The idea, still being characterized, is that hitting GLP-1 and amylin pathways together produces more appetite suppression than either alone. Both components are engineered for slow release so a single weekly dose maintains steady drug levels.

Is CagriSema FDA approved?

No, CagriSema is not currently FDA approved. Current status: NDA Submitted (Dec 18, 2025) - FDA decision expected Q4 2026. First once-weekly combination of GLP-1 and amylin analogues for weight management.

What are the side effects of CagriSema?

Reported side effects include: Nausea, Vomiting, Diarrhea, Constipation, GI events (72-80% vs 34-40% placebo). Individual responses vary based on dosage, duration, and personal health factors.

What is the typical dose of CagriSema?

Community-reported common dose: Limited community data available (See research protocols). Range: See research dosing. Administration: Subcutaneous injection weekly. Community-reported doses. Not medical advice. Consult healthcare provider.

Related Peptides

Peptides commonly compared with CagriSema or used in similar applications.

Tirzepatide

FDA

Tirzepatide is a single peptide that activates two receptors at once: GIP and GLP-1, the two main incretin hormones your gut releases after eating. It is FDA-approved as Mounjaro for type 2 diabetes and as Zepbound for chronic weight management and obstructive sleep apnea, and it has produced the largest weight-loss numbers of any approved drug to date. Like semaglutide, this is a heavily trialed, fully approved medicine, not a gray-market research compound.

Weight Loss

Liraglutide

FDA

Liraglutide is a once-daily injectable GLP-1 receptor agonist, a synthetic peptide that shares about 97% of its sequence with the natural gut hormone GLP-1 but is engineered with a fatty acid chain so it survives in the body far longer. It is FDA-approved as Victoza for type 2 diabetes (2010) and as Saxenda for chronic weight management (2014), and is one of the most studied drugs in its class. As of 2024 a generic version is also FDA-approved.

Weight Loss

Dulaglutide

FDA

Dulaglutide (brand name Trulicity) is a once-weekly injectable GLP-1 receptor agonist made by fusing a modified GLP-1 peptide to a fragment of a human antibody, which is what lets it last a full week between shots. It is FDA-approved for type 2 diabetes and, notably, to reduce cardiovascular risk in adults with diabetes. The once-weekly dosing made it a major convenience step up from earlier daily and twice-daily agents.

Weight Loss

Cagrilintide

Clinical Trials

Cagrilintide (also called AM833) is a long-acting synthetic analog of amylin, the gut-brain satiety hormone co-secreted with insulin by pancreatic beta cells. It is an investigational once-weekly injectable being developed by Novo Nordisk for obesity, most prominently as the amylin half of CagriSema (cagrilintide plus semaglutide). It is not yet approved as a standalone drug, but it has cleared phase 2 trials and is in late-stage development.

Weight Loss

Eloralintide

Clinical Trials

Eloralintide (Eli Lilly code LY3841136) is an investigational, long-acting, selective amylin receptor agonist given as a once-weekly subcutaneous injection for obesity. Amylin is the satiety hormone your pancreas releases alongside insulin, and eloralintide is built to mimic it without the gut side effects that sink most appetite drugs. It is not approved anywhere yet, but it has cleared Phase 1 and a 263-person Phase 2 trial with weight loss up to roughly 20 percent, and Lilly has said it is moving into Phase 3.

Weight Loss

Semaglutide

FDA

Semaglutide is a GLP-1 receptor agonist, a peptide engineered to mimic the natural gut hormone GLP-1 but with a roughly week-long half-life so it can be dosed once weekly. It is FDA-approved and sold as Ozempic and Rybelsus for type 2 diabetes and as Wegovy for chronic weight management, with cardiovascular benefit also on the label. This is one of the most rigorously tested peptides in existence, backed by large randomized trials, so the evidence here is in a completely different league from research-only peptides.

Weight Loss

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