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
2 other identifiers
interventional
103
1 country
5
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 obesity
Started Feb 2022
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 8, 2021
CompletedStudy Start
First participant enrolled
February 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedFebruary 5, 2026
February 1, 2026
1 year
November 4, 2021
February 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26
Baseline and Week 26
Secondary Outcomes (28)
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
- +23 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants in the placebo arm received volume- and regimen-matched placebo.
CT-868 1.75 mg
EXPERIMENTALParticipants 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.
CT-868 4.0 mg
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Males or Females with T2DM
- BMI of ≥27 kg/m2, inclusive
- years old, inclusive
- Stable body weight for 3 months
You may not qualify if:
- Significant medical history
- Uncontrolled diabetes
- History of malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carmot Therapeutics, Inc.lead
- Hoffmann-La Rochecollaborator
Study Sites (5)
Carmot Clinical Center MX04
Guadalajara, Jalisco, Mexico
Carmot Clinical Center MX01
Monterrey, Nuevo León, Mexico
Carmot Clinical Center MX02
Monterrey, Nuevo León, Mexico
Carmot Clinical Center MX05
Mérida, Yucatán, Mexico
Carmot Clinical Center MX03
Mexico City, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Carmot Therapeutics, Inc., a Member of the Roche Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2021
First Posted
November 8, 2021
Study Start
February 22, 2022
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share