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

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Center Study to Evaluate the Efficacy, Safety, and Tolerability of CT-868 Administered for 26 Weeks to Overweight and Obese Participants With Type 2 Diabetes Mellitus

A study to assess the effect of CT-868 in lowering glycated hemoglobin A1c (HbA1c) in overweight and obese participants with inadequately controlled Type 2 diabetes mellitus (T2DM).

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: CT-868

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Carmot Clinical Center MX03
  • Jalisco
    • Guadalajara, Jalisco, Mexico
      • Carmot Clinical Center MX04
  • Nuevo León
    • Monterrey, Nuevo León, Mexico
      • Carmot Clinical Center MX01
    • Monterrey, Nuevo León, Mexico
      • Carmot Clinical Center MX02
  • Yucatán
    • Mérida, Yucatán, Mexico
      • Carmot Clinical Center MX05

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Significant medical history
• Uncontrolled diabetes
• History of malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants in the placebo arm received volume- and regimen-matched placebo.	Drug: Placebo; Participants self-injected once-daily subcutaneous volume- and regimen-matched placebo for 26 weeks.
Experimental: CT-868 1.75 mg; Participants in the CT-868 1.75 mg arm received 1.0 mg/day for 2 weeks followed by 1.75 mg/day for the remaining treatment period.	Drug: CT-868; Participants self-injected once-daily subcutaneous CT-868 for 26 weeks according to the randomized dose and regimen.
Experimental: CT-868 4.0 mg; Participants in the CT-868 4.0 mg arm escalated through 1.0 mg/day for 2 weeks, 1.75 mg/day for 2 weeks, 2.5 mg/day for 4 weeks, 3.25 mg/day for 4 weeks, to 4.0 mg/day for the remaining 14 weeks.	Drug: CT-868; Participants self-injected once-daily subcutaneous CT-868 for 26 weeks according to the randomized dose and regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26	Baseline and Week 26

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in HbA1c at Week 12	Baseline and Week 12
Percentage of Participants Achieving HbA1c <5.7% at Weeks 12 and 26	Baseline and Weeks 12 and 26
Percentage of Participants Achieving HbA1c ≤6.5% at Weeks 12 and 26	Baseline and Weeks 12 and 26
Percentage of Participants Achieving HbA1c <7.0% at Weeks 12 and 26	Baseline and Weeks 12 and 26
Percent Change from Baseline in Body Weight at Weeks 12 and 26	Baseline and Weeks 12 and 26
Absolute (kg) Change from Baseline in Body Weight at Weeks 12 and 26	Baseline and Weeks 12 and 26
Percentage of Participants with ≥5% Body Weight Loss from Baseline at Weeks 12 and 26	Baseline and Weeks 12 and 26
Percentage of Participants with ≥10% Body Weight Loss from Baseline at Weeks 12 and 26	Baseline and Weeks 12 and 26
Percentage of Participants with ≥15% Body Weight Loss from Baseline at Weeks 12 and 26	Baseline and Weeks 12 and 26
Percentage of Participants with ≥20% Body Weight Loss from Baseline at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Fasting Plasma Glucose at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Fasting Insulin at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Waist Circumference at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Hip Circumference at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Waist-to-Hip Ratio at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Waist-to-Height Ratio at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Body Mass Index (BMI) at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Total Cholesterol at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Triglycerides at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in High Density Lipoprotein (HDL) Cholesterol at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Apolipoprotein B at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Weeks 12 and 26	Baseline and Weeks 12 and 26
Change from Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) at Weeks 12 and 26	Baseline and Weeks 12 and 26
Percentage of Participants with at Least One Treatment-Emergent Adverse Event	From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks)
Percentage of Participants with at Least One Hypoglycemic Event	From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks)
Percentage of Participants Testing Positive for Anti-Drug Antibodies to CT-868 at Baseline and Anytime Post-Baseline	Baseline and Post-Baseline (up to 30 weeks)

Collaborators and Investigators

• Sponsor: Carmot Therapeutics, Inc.
• Collaborators: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Carmot Therapeutics, Inc., a Member of the Roche Group

Publications and helpful links

Helpful Links

• Carmot Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CT-868-002; BP45664 (Other Identifier: Roche Protocol Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes