NCT05814107

Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus

A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CT-996 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Carmot Australia First Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with Type 2 Diabetes Mellitus (T2DM).

Detailed description

This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single ascending doses (SAD) and multiple-ascending doses (MAD) in overweight/obese participants and as multiple doses (MD) in patients with T2DM.

Conditions

• Type 2 Diabetes
• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	CT-996	Capsule of CT-996
DRUG	Placebo	Capsule of placebo matching CT-996.

Timeline

• Start date: 2023-05-09
• Primary completion: 2025-11-07
• Completion: 2025-11-07
• First posted: 2023-04-14
• Last updated: 2025-11-28

Locations

2 sites across 2 countries: Australia, Mexico