NCT06628362

A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Weekly CT-388 Administered Subcutaneously for 48 Weeks to Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Carmot Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).

Conditions

• Overweight or Obese
• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Placebo	Placebo will be volume-matched and administered subcutaneously (SC) once weekly.
DRUG	Enicepatide	Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.

Timeline

• Start date: 2024-11-21
• Primary completion: 2026-06-01
• Completion: 2026-09-24
• First posted: 2024-10-08
• Last updated: 2026-04-17

Locations

70 sites across 6 countries: United States, Argentina, Canada, Mexico, New Zealand, Puerto Rico

Regulatory

• FDA-regulated drug study