PeptideTreatments
Reviewed by Peptide Treatments Medical Advisory Board

CagriSema: Research & Evidence

Established Evidence

Published research, clinical trial data, and evidence grading for CagriSema across studied indications.

Back to CagriSema overview

Research Summary

CagriSema has completed its Phase 3 COMPASS trial program with over 7,000 total subjects exposed, achieving 22-25% weight loss at 68 weeks in large, well-designed RCTs. The NDA was submitted to the FDA in Q3 2025 with a potential PDUFA date in August 2026. Key unknowns include cardiovascular outcomes data (trial ongoing) and head-to-head results versus tirzepatide (COMPARE trial pending).

Evidence by Indication (3 indications)

Indication Tier Trials Summary
Chronic weight management Tier A 6 Phase 3 COMPASS program — 22-25% weight loss in 7,000+ subjects
Type 2 diabetes with obesity Tier B 2 18.4% weight loss in T2D population (COMPASS-2)
Cardiovascular risk reduction Tier D 1 CVOT ongoing — no outcomes data yet

Graded using our evidence tier methodology.

Research Gap Score /10

Higher score = larger gap between therapeutic potential and available clinical evidence.

Citations (4 sources)

  1. 1. CagriSema Phase 3 COMPASS-1 Trial: Weight Loss Efficacy Clinical Trial

    Novo Nordisk (2025), New England Journal of Medicine

  2. 2. CagriSema Phase 3 COMPASS-2 Trial: Obesity with T2D Clinical Trial

    Novo Nordisk (2025), Lancet

  3. 3. CagriSema Phase 2 REDEEM-1: Dose-Ranging Study Clinical Trial

    Multiple authors (2024), Lancet

  4. 4. CagriSema Phase 2 REDEEM-2: Obesity with T2D Clinical Trial

    Multiple authors (2024), Diabetes Care