A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus

Phase 2

• Conditions: Obesity; Type2 Diabetes
• Interventions: Drug: Placebo; Drug: CT-868

• Registration Number: NCT05110846
• Lead Sponsor: Carmot Therapeutics, Inc.

Brief Summary

A Study to Assess the effect of CT-868 in hemoglobin A1c (HbA1c) in Overweight and Obese Participants with Type 2 Diabetes Mellitus.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-08
• Status Verified: 2022-02
• Study Start: 2022-02-22
• Last Update Submitted: 2022-07-24
• Last Update Posted: 2022-07-26
• Primary Completion: 2023-02
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Males or Females with T2DM
• BMI of ≥27 kg/m2, inclusive
• 18-75 years old, inclusive
• Stable body weight for 3 months

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Exclusion Criteria

• Significant medical history
• Uncontrolled diabetes
• History of malignancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
CT-868 Low Dose	CT-868	CT-868
CT-868 Maximum Tolerated Dose	CT-868	CT-868

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin A1c (HbA1c)	Baseline up to 12 and 26 weeks

Secondary Outcome Measures

Name	Time	Method
Change in mean body weight	Baseline up to 12 and 26 weeks
Fasting plasma glucose	Baseline up to 12 and 26 weeks

Trial Locations

Locations (6)

Carmot Clinical Center MX05; 🇲🇽 Mérida, Yucatan, Mexico

Carmot Clinical Center MX03; 🇲🇽 Mexico City, Mexico

Carmot Clinical Center MX04; 🇲🇽 Guadalajara, Jalisco, Mexico

Carmot Clinical Center MX01; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Carmot Clinical Center US01; 🇺🇸 Los Angeles, California, United States

Carmot Clinical Center MX02; 🇲🇽 Monterrey, Nuevo Leon, Mexico