A Randomized, Double-Blind Study of The Efficacy and Safety of Trevogrumab, With or Without Garetosmab, in Addition to Semaglutide in Patients With Obesity

Registration

Registration

NCT06299098

Acronym

COURAGE

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

QUADRUPLE

Status

ACTIVE_NOT_RECRUITING

Enrollment

1005

Start

2024-03-13

Primary completion

2026-06-16

Lead sponsor

Regeneron Pharmaceuticals

Conditions

Obesity

Interventions

DRUG:Trevogrumab-Part A; DRUG:Trevogrumab-Part B and Part C; DRUG:Garetosmab; DRUG:Semaglutide; DRUG:Matching Placebo-Part A; DRUG:Matching Placebo-Trevogrumab; DRUG:Matching Placebo-Garetosmab

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Incidence of treatment-emergent adverse events (TEAEs) [Baseline to week 7]
• Severity of TEAEs [Baseline to week 7]
• Percent change in total fat mass [Baseline to week 26]
• Percent change in total lean mass [Baseline to week 26]
• Percent change in body weight [Baseline to week 26]
• Percent change in total fat mass [Baseline to week 52]
• Percent change in total lean mass [Baseline to week 52]
• Percent change in body weight [Baseline to week 52]