What does CagriSema do?

CagriSema is an investigational combination of semaglutide and cagrilintide studied for obesity, weight management and type 2 diabetes. The source describes it as a weekly injectable that targets GLP-1 and amylin-related appetite pathways.

Is CagriSema FDA approved?

No. The supplied source lists CagriSema as not FDA approved and separately reports an NDA submission dated Dec 18, 2025 with a decision expected in Q4 2026.

What are the side effects of CagriSema?

The source lists gastrointestinal adverse effects, including nausea, vomiting, diarrhea and constipation. It also reports gastrointestinal events at 72-80% compared with 34-40% for placebo and notes higher gastrointestinal effects than semaglutide alone.

What is the typical dose of CagriSema?

The community dose field says limited community data are available. The research dosing row lists semaglutide 2.4 mg plus cagrilintide 2.4 mg once weekly by subcutaneous injection in phase 3 clinical-trial context.

Weight Loss Clinical Trials - human trials under way

CagriSema

Also known as: Semaglutide + Cagrilintide

At a glance

PeptiGuide dataset · reviewed Aug 2026

What it is

Investigational semaglutide and cagrilintide blend for weight-management research

Status

Clinical Trials

Evidence level: human studies

Typical dose

2.4mg

Subcutaneous injection weekly

Researched for

Maximum weight loss, combination therapy, obesity

Trial progress

PrePreclinical
IPhase I
IIPhase II
IIIPhase III
IVPhase IV
FDAFDA approved

Phase III - Emerging human evidence with important limitations

Use the tools

In plain language

CagriSema is a research-stage blend of semaglutide and cagrilintide developed for obesity and type 2 diabetes. The supplied source reports phase 3 REDEFINE trial data and an NDA submission, while also stating that it is not FDA approved. Research dosing in the source is semaglutide 2.4 mg plus cagrilintide 2.4 mg once weekly by injection. Reported adverse effects are mainly gastrointestinal.

How it's thought to work

CagriSema combines semaglutide, a receptor , with cagrilintide, a long-acting amylin analog. The source links semaglutide to insulin response after meals, delayed gastric emptying and fullness signaling, while cagrilintide is described as acting through amylin-related satiety pathways in the brain. The proposed research rationale is that concurrent GLP-1 and amylin signaling may produce stronger appetite effects than either pathway alone.

What the research shows

Where the research stands

The supplied research summary describes two phase 3 REDEFINE studies. In REDEFINE 1, about 3,400 adults with overweight or obesity without diabetes were followed for 68 weeks; reported average body-weight change was about 20.4% with CagriSema, compared with 14.9% for semaglutide, 11.5% for cagrilintide and 3.0% for placebo. REDEFINE 2 enrolled adults with type 2 diabetes and is described as meeting endpoints for weight reduction and HbA1c improvement versus placebo. The source also notes that the approximately 20% result was below Novo Nordisk's 25% target, and that gastrointestinal events were the most common adverse effects.

What it shows

✓ Human studies

Emerging human evidence with important limitations

△ Limitations

Study protocols describe research and are not dosing recommendations.

Bottom line: NDA submitted Dec 18, 2025; FDA decision expected Q4 2026. Not FDA approved; NDA submitted Dec 18, 2025.

Typical dosing

CommunityCommunity dataset

Limited community data available

See research protocols

Range: See research dosing

Community-sourced dosing information is limited and points back to research protocols rather than a well-characterized community pattern.

Research dosing

Study-specific protocolsHuman trials under way - protocols are study-specific

Doses observed in studies

Semaglutide 2.4 mg + cagrilintide 2.4 mg weekly

Clinical Trial Data - Phase 3 Clinical Trials

Study protocols describe research and are not dosing recommendations.

Duration: Long-term use expected
Administration: Subcutaneous injection weekly
Frequency: Weekly

Timing & administration

Possible side effects

Not everyone experiences these. Individual responses vary with dose, duration, and personal factors.

Nausea
Vomiting
Diarrhea
Constipation
Gastrointestinal events
Higher gastrointestinal effects than semaglutide alone
Investigational status

Not everyone experiences side effects, and severity can vary by context, purity, route, and individual health factors.

Sources

PubMed ClinicalTrials.gov FDA.gov

Frequently asked questions

The semaglutide component acts through GLP-1 receptor signaling, which is associated in the source with post-meal insulin effects, slower gastric emptying and satiety signaling. Cagrilintide is described as a long-acting amylin analog that may reduce food intake through additional brain appetite circuits. The rationale is dual engagement of GLP-1 and amylin biology rather than a single appetite pathway.

One open dataset

Every fact on this page - doses, side effects, references - comes from the same PeptiGuide dataset that powers the Tracker, Compare, and the Lab.

Browse the dataset

Save to my research list Get updates on CagriSema

Educational resource, not medical advice. Talk to your clinician before acting on anything here.

Community discussion

Comments are moderated before they appear. Keep it evidence-focused.

CagriSema

In plain languageIn plain language

How it's thought to workHow it's thought to work

What the research showsWhat the research shows

Typical dosing

Research dosing

Timing & administrationTiming & administration

Possible side effectsPossible side effects

SourcesSources

Frequently asked questionsFrequently asked questions