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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

amylin analogue (cagrilintide) + GLP-1 (semaglutide) combination

13
graded findings
7
effect domains
Evidence spread
High evidence 7Moderate evidence 2Low evidence 2Very low evidence 2

CagriSema is shown as an investigational or pipeline evidence record. Findings describe what studies and reports observed; they do not endorse use or establish personal suitability.

CagriSema INVESTIGATIONAL
Weight change 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
Scope limitsMechanism: dual amylin + GLP-1 pathway. Headline Dec 2024, full data ADA/NEJM 2025. The 'fell short of 25%' framing recorded AS REPORTED commentary, not a verdict. REDEFINE 2 (T2D) is the companion trial.
Comparatorsplacebo; semaglutide 2.4 mg; cagrilintide 2.4 mg
CagriSema INVESTIGATIONAL
Weight change 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
Scope limitsconference/abstract-level; magnitude web/secondary-sourced
Comparatorsplacebo; semaglutide 2.4 mg; cagrilintide 2.4 mg
CagriSema INVESTIGATIONAL
Weight change 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
Scope limitsDiabetes attenuates weight loss vs non-diabetic REDEFINE 1
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
Scope limitsConference-reported; numerics pending publication
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)
Scope limitsconference/abstract-level
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
Scope limitspost-hoc (not prespecified)
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)
Scope limitsDOI from publisher page, not PubMed-verified - identifier needs confirmation.
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
Gastrointestinal tolerability 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
Scope limitsAdds the REDEFINE-2 GI-AE table (the efficacy is already in the corpus). Shares source PMID 40544432.
CagriSema INVESTIGATIONAL
Gastrointestinal tolerability 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
Scope limitsconference/abstract-level; magnitude web/secondary-sourced
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
Glycaemic control 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
Scope limitsPrimary endpoints were weight, not glycaemia; HbA1c reported as proportion reaching ≤6.5% rather than mean Δ in abstract. Placebo-controlled (no semaglutide head-to-head arm here).
Comparatorsplacebo
CagriSema INVESTIGATIONAL
Glycaemic control 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)
Scope limitsidentifier not fully verified
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
renal Not directional
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)
Scope limitsNo human renal results as of search date; entry records the registered trial and data absence. NCT from web; date = search date.
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
Safety signals 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
Scope limitsconference/abstract-level; magnitude web/secondary-sourced
Comparatorsplacebo; semaglutide 2.4 mg; cagrilintide 2.4 mg