NCT06970405

Study of Safety and Effects of Garetosmab in Healthy Obese Men and Post-Menopausal Women

Randomized, Double-Blind, Placebo-Controlled Study of Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Garetosmab in Men and Post-Menopausal Women With Obesity Who Are Otherwise Healthy

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is researching an experimental drug called garetosmab, referred to as "study drug". The study is focused on otherwise healthy participants with obesity. The aim of the study is to see how safe and tolerable the study drug is. The study is looking at several other research questions, including: * How much study drug is in the blood at different times * What effect the study drug has on the blood clotting * What effect the study drug has on hormone levels * What effect the study drug has on some organs that produce hormones * What effect hormones have on the side effects produced by the study drug * Whether the body makes antibodies against the study drug (which could change how well the drug works or could lead to side effects)

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Garetosmab	Administered per the protocol
DRUG	Matching Placebo	Administered per the protocol

Timeline

• Start date: 2025-05-29
• Primary completion: 2026-06-08
• Completion: 2026-06-08
• First posted: 2025-05-14
• Last updated: 2025-09-17

Regulatory

• FDA-regulated drug study