Evidence reference only. Not medical advice, not a dosing guide, and not a recommendation to use any drug.
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Investigational and unapproved. Findings below describe what trials and reports have observed. Nothing here is an endorsement, a claim of safety or effectiveness, or a clinical recommendation.

CagriSema

INVESTIGATIONAL

Long-acting amylin analogue combined with GLP-1 receptor agonism

14
graded results
1
ongoing records
7
effect domains
Evidence spread
High evidence 9Moderate evidence 2Low evidence 2Very low evidence 1

CagriSema is investigational in the scoped programme below. Study records do not establish approval, safety or personal suitability. Results describe observations and do not provide treatment advice.

Dated status sources

INVESTIGATIONAL United States; Chronic weight management; Fixed-dose subcutaneous combination; as of 2026-07-13. Novo Nordisk

The grade rates how strong the evidence is, not how good or safe the drug is. A low or very-low grade means the evidence is thin, not that an effect is harmful or ruled out.

CagriSema INVESTIGATIONAL
weight-loss Decrease
High evidence

In phase 3 REDEFINE 1, once-weekly CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg) gave 22.7% mean weight reduction at 68 weeks vs 3% placebo in...

Coadministered Cagrilintide and Semaglutide in Overweight/Obesity, NEJM 2025 (REDEFINE 1)... Source
Full findingIn phase 3 REDEFINE 1, once-weekly CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg) gave 22.7% mean weight reduction at 68 weeks vs 3% placebo in overweight/obesity without T2D (efficacy estimand; treatment-policy ~20.4%). 40.4% reached >=25% weight loss (vs 16.2% sema, 6.0% cagrilintide, 0.9% placebo); 88% with prediabetes returned to normoglycaemia. As reported, the 22.7% fell short of the company's pre-trial ~25% expectation, prompting commentary that the result underwhelmed expectations.
PopulationREDEFINE 1: 3,417 adults obesity/overweight + >=1 comorbidity, no T2D; 68 wk; randomised 21:3:3:7 CagriSema:semaglutide:cagrilintide:placebo
Fundingindustry - Novo Nordisk
Comparatorsplacebo; semaglutide 2.4 mg; cagrilintide 2.4 mg
CagriSema INVESTIGATIONAL
weight-loss Decrease
High evidence

REDEFINE 1: substantial weight loss vs placebo and vs each monocomponent in obesity without diabetes

Garvey WT, Blüher M, et al. N Engl J Med 2025 (REDEFINE 1) Source
PopulationAdults BMI ≥30 or ≥27+complication, no diabetes (n=3417; 2108 CagriSema), phase 3a, 68 wk, RCT placebo+active controlled (NCT05567796)
Fundingindustry-Novo Nordisk
Comparatorsplacebo; semaglutide 2.4 mg; cagrilintide 2.4 mg
CagriSema INVESTIGATIONAL
weight-loss Decrease
High evidence

REDEFINE 2: weight loss vs placebo in obesity WITH type 2 diabetes

Davies MJ, Bajaj HS, et al. N Engl J Med 2025 (REDEFINE 2) Source
PopulationAdults BMI ≥27, HbA1c 7-10%, T2D (n=1206; 904 CagriSema), phase 3a, 68 wk, RCT placebo-controlled (NCT05394519)
Fundingindustry-Novo Nordisk
Comparatorsplacebo
Thin or bounded evidence here means uncertainty remains visible. It is not evidence that an effect has been ruled out.
CagriSema INVESTIGATIONAL
body-composition Decrease
Moderate evidence

Promotes fat-mass reduction and enhances physical function (ObesityWeek 2025)

Lau et al., Lancet 2021 (phase 2); Novo Nordisk REDEFINE 1, NEJM 2025 Source
PopulationREDEFINE 1 substudy (n up to 3417), 68 wk
Fundingindustry - Novo Nordisk
Comparatorsplacebo; semaglutide 2.4 mg; cagrilintide 2.4 mg
CagriSema INVESTIGATIONAL
body-composition Decrease
Low evidence

REDEFINE-1 DXA subgroup (Week 68): CagriSema produced the greatest weight reduction; of weight lost, 66.9% was fat mass and 33.1% lean soft tissue. In participants...

Ravussin E et al., REDEFINE-1 body composition, ObesityWeek 2025 / ECO 2026 presentations... Source
Full findingREDEFINE-1 DXA subgroup (Week 68): CagriSema produced the greatest weight reduction; of weight lost, 66.9% was fat mass and 33.1% lean soft tissue. In participants achieving >=30% weight loss, fat-mass proportion fell from 46.3% to 33.2% while lean-soft-tissue proportion rose from 51.3% to 63.2%.
PopulationDXA subgroup of REDEFINE-1 RCT in overweight/obesity; CagriSema 2.4/2.4 mg vs semaglutide 2.4 mg vs cagrilintide 2.4 mg vs placebo; 68 weeks
Fundingacademic/independent analysis (manufacturer not study sponsor; per-study COI not individually audited)
Comparatorssemaglutide; cagrilintide; placebo
Thin or bounded evidence here means uncertainty remains visible. It is not evidence that an effect has been ruled out.
CagriSema INVESTIGATIONAL
blood-pressure Decrease
Moderate evidence

Clinically relevant BP reductions including in resistant hypertension (REDEFINE 1 post hoc)

Verma S et al. Hypertension 2025;83:e26055 Source
PopulationObese/overweight no diabetes (n=3417), phase 3a post hoc, 68 wk
Fundingindustry-Novo Nordisk
Comparatorsplacebo; semaglutide 2.4 mg; cagrilintide 2.4 mg
CagriSema INVESTIGATIONAL
blood-pressure Decrease
Low evidence

CagriSema reduced SBP versus placebo and versus semaglutide alone in REDEFINE 1.

REDEFINE 1 BP analysis, Hypertension, 2025/2026 Source
PopulationAdults without diabetes, BMI >=30 or >=27 + complication; REDEFINE 1 phase 3a; 68 weeks.
Fundingacademic/independent analysis (manufacturer not study sponsor; per-study COI not individually audited)
Comparatorssemaglutide 2.4 mg; cagrilintide 2.4 mg; placebo
Thin or bounded evidence here means uncertainty remains visible. It is not evidence that an effect has been ruled out.
CagriSema INVESTIGATIONAL
Stomach and gut Increase
High evidence

In the T2D registrational trial, CagriSema roughly doubled gastrointestinal adverse events versus placebo (72.5% vs 34.4%), mostly transient.

Davies MJ, Bajaj HS, et al. N Engl J Med 2025 (REDEFINE 2) Source
PopulationPeer-reviewed RCT / meta-analysis
Fundingindustry-Novo Nordisk
CagriSema INVESTIGATIONAL
Stomach and gut Increase
High evidence

GI AEs much more frequent than placebo, mainly transient and mild-to-moderate; GI-specific discontinuation modest.

Garvey WT, Blüher M, et al. N Engl J Med 2025 (REDEFINE 1) Source
PopulationREDEFINE 1: 3417 adults overweight+complication or obesity, no diabetes; 68 weeks; phase 3a RCT
Fundingindustry-Novo Nordisk
Comparatorssemaglutide 2.4 mg; cagrilintide 2.4 mg; placebo
Thin or bounded evidence here means uncertainty remains visible. It is not evidence that an effect has been ruled out.
CagriSema INVESTIGATIONAL
Head-to-head comparisons Increase
High evidence

ACTIVE-CONTROLLED head-to-head within trial (REDEFINE 1, obesity without T2D). CagriSema (cagri 2.4 mg + sema 2.4 mg) gave -20.4% weight vs placebo -3.0% (difference...

Garvey WT, Blüher M, et al. N Engl J Med 2025 (REDEFINE 1) Source
Full findingACTIVE-CONTROLLED head-to-head within trial (REDEFINE 1, obesity without T2D). CagriSema (cagri 2.4 mg + sema 2.4 mg) gave -20.4% weight vs placebo -3.0% (difference -17.3 pp) at 68 weeks; trial also contained semaglutide 2.4 mg monotherapy (N=302) and cagrilintide 2.4 mg monotherapy (N=302) arms enabling within-trial comparison of the combination against each component.
Population3417 adults with overweight/obesity without diabetes, double-blind placebo- and active-controlled phase 3a, 68 weeks; randomised 21:3:3:7 (combo:sema:cagri:placebo)
Fundingindustry-Novo Nordisk
Comparatorsplacebo; semaglutide 2.4 mg; cagrilintide 2.4 mg
CagriSema INVESTIGATIONAL
Head-to-head comparisons Increase
High evidence

ACTIVE/placebo-controlled (REDEFINE 2, overweight/obesity WITH T2D). CagriSema -13.7% vs placebo -3.4% weight at 68 weeks (difference -10.4 pp). HbA1c <=6.5% reached...

Davies MJ, Bajaj HS, et al. N Engl J Med 2025 (REDEFINE 2) Source
Full findingACTIVE/placebo-controlled (REDEFINE 2, overweight/obesity WITH T2D). CagriSema -13.7% vs placebo -3.4% weight at 68 weeks (difference -10.4 pp). HbA1c <=6.5% reached by 73.5% (CagriSema) vs 15.9% (placebo).
Population1206 adults with T2D and BMI >=27, double-blind, 68 weeks, randomised 3:1 vs placebo
Fundingindustry-Novo Nordisk
Comparatorsplacebo
Thin or bounded evidence here means uncertainty remains visible. It is not evidence that an effect has been ruled out.
CagriSema INVESTIGATIONAL
glycaemic Decrease
High evidence

In REDEFINE 2 (phase 3a, T2D + overweight/obesity), CagriSema markedly increased the proportion of patients reaching HbA1c ≤6.5% vs placebo at 68 weeks (glycaemic...

Davies MJ, Bajaj HS, et al. N Engl J Med 2025 (REDEFINE 2) Source
Full findingIn REDEFINE 2 (phase 3a, T2D + overweight/obesity), CagriSema markedly increased the proportion of patients reaching HbA1c ≤6.5% vs placebo at 68 weeks (glycaemic endpoints secondary; primary was weight).
Population1206 adults with T2D, BMI ≥27, HbA1c 7-10%; 68-week double-blind placebo-controlled phase 3a RCT, 12 countries; CGM substudy
Fundingindustry-Novo Nordisk
Comparatorsplacebo
CagriSema INVESTIGATIONAL
glycaemic Decrease
Very low evidence

Per Novo Nordisk press release, in REIMAGINE 2 CagriSema 2.4/2.4 mg gave superior HbA1c reduction vs semaglutide 2.4 mg in T2D at 68 weeks (head-to-head).

Novo Nordisk press release: CagriSema demonstrated superior HbA1c reduction of 1.91%-poin... Source
PopulationAdults with T2D on metformin ± SGLT2i; 68-week phase 3 RCT; comparator semaglutide 2.4 mg
Fundingindustry - Novo Nordisk (trial sponsor; inferred from registration trial)
Comparatorssemaglutide 2.4 mg
Thin or bounded evidence here means uncertainty remains visible. It is not evidence that an effect has been ruled out.
CagriSema INVESTIGATIONAL
safety-other Increase
High evidence

In REDEFINE 1, GI AEs common but AE-related discontinuation modest; only a small fraction discontinued specifically for GI events.

Garvey WT, Blüher M, et al. N Engl J Med 2025 (REDEFINE 1) Source
PopulationREDEFINE 1 phase 3, adults with overweight/obesity without T2D
Fundingindustry-Novo Nordisk
Comparatorsplacebo; semaglutide 2.4 mg; cagrilintide 2.4 mg

Registered or protocol records without results

These records remain discoverable, but they are not counted or presented as results.

CagriSema INVESTIGATIONAL
renal Not directional REGISTERED, NO RESULTS
Very low evidence

No published renal-outcome results; a dedicated phase 2 CKD RCT is registered but results not yet available.

ClinicalTrials.gov NCT06131372 Source
PopulationRegistry record; REDEFINE 1/2 reported weight but no renal endpoints.
Fundingindustry/sponsor of record - Novo Nordisk A/S (disclosed via registry)
Comparatorssemaglutide; cagrilintide; placebo