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NCT05814107 Clinical Trial

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

Type 2 Diabetes Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05814107
Other study ID # CT-996-201
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 9, 2023
Est. completion date November 2024

Study information
Verified date March 2023
Source Carmot Therapeutics, Inc.
Contact Michael Elliott
Phone 510-666-6328
Email melliott@carmot.us
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 118
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• CT-996
Capsule of CT-996
• Placebo
Capsule of Placebo

Locations
Country Name City State
Australia Carmot Clinical Research Unit 101 Melbourne

Sponsors (2)
Lead Sponsor Collaborator
Carmot Australia First Pty Ltd Carmot Therapeutics, Inc.

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events in CT-996 participants To evaluate the safety and tolerability of CT-996 Baseline up to 28 days
Secondary Maximum observe drug concentration (Cmax) of CT-996 PK Cmax Baseline up to 28 days
Secondary Effect of a High-Fat Meal on Plasma Concentration of CT-996 Determine the effect of a high-fat meal on the PK of CT-996 following a single dose Baseline up to 14 days
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