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cagrilintide amylin agonist rct n=331 2023-04-03 ClinicalTrials

CagriSema Phase 3 Trial Completes Enrollment for Weight Loss in East Asia

A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight

Background

The global prevalence of obesity and overweight continues to rise, posing significant public health challenges and increasing the risk of numerous comorbidities like type 2 diabetes and cardiovascular disease. While effective weight management therapies exist, there's a continuous need for more potent and well-tolerated options, especially for diverse populations. This study addresses the knowledge gap by specifically evaluating the efficacy and safety of the novel combination therapy CagriSema in East Asian participants.

Study Design

Population
331 East Asian participants with obesity or overweight.
Intervention
CagriSema, a novel combination therapy.
Comparator
placebo
Outcome
Percentage change in body weight from baseline.

Results

As this is a recently completed Phase 3 clinical trial in terms of enrollment, specific efficacy and safety results are not yet publicly available. The study successfully enrolled its target of 331 East Asian participants, demonstrating the feasibility of conducting such a large-scale trial in this demographic. The primary outcome measure is designed to assess the percentage change in body weight from baseline, aiming to show significant weight reduction compared to placebo. Secondary outcomes will evaluate improvements in metabolic markers such as waist circumference and body mass index (BMI), alongside a comprehensive assessment of the incidence of adverse events and overall safety profile. > While specific efficacy and safety results are currently pending, the successful completion of enrollment marks a significant milestone for this CagriSema study.

Why It Matters

The successful completion of enrollment for this Phase 3 trial is a crucial step towards potentially offering a highly effective new treatment option for obesity. If the results demonstrate significant weight loss and a favorable safety profile, CagriSema could become a leading therapy. This study is particularly important as it specifically investigates the drug's performance in East Asian populations, addressing potential ethnic differences in drug response and metabolism. Positive outcomes could pave the way for regulatory submissions and broader availability of this combination therapy.


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Source: clinicaltrials:NCT05813925 · Ingested 2026-04-28 · Digest: gemini-2.5-flash