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

Phase 1

Recruiting

• Conditions: Type 2 Diabetes; Overweight or Obesity
• Interventions: Drug: CT-996; Drug: Placebo

• Registration Number: NCT05814107
• Lead Sponsor: Carmot Australia First Pty Ltd

Brief Summary

A study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with T2DM.

Detailed Description

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 and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.

Study Timeline

• Study First Submitted: 2023-02-23
• Status Verified: 2023-03
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-14
• Study Start: 2023-05-09
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Participants 18-65 years old, inclusive
• BMI of 25 - 40, inclusive
• Stable body weight for two months

Exclusion Criteria

• History of significant medical conditions and malignancy
• Uncontrollable hypertension
• History of alcoholism or drug addiction within 1 year prior to Screening
• Current or recent participation in an investigational clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CT-996	CT-996	Capsule of CT-996 intervention
Placebo	Placebo	Capsule of placebo matching CT-996 dose

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events in CT-996 participants	Baseline up to 28 days	To evaluate the safety and tolerability of CT-996

Secondary Outcome Measures

Name	Time	Method
Maximum observe drug concentration (Cmax) of CT-996	Baseline up to 28 days	PK Cmax
Effect of a High-Fat Meal on Plasma Concentration of CT-996	Baseline up to 14 days	Determine the effect of a high-fat meal on the PK of CT-996 following a single dose

Trial Locations

Locations (1)

Carmot Clinical Research Unit 101; 🇦🇺 Melbourne, Australia