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

February 3, 2026 updated by: Carmot Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26
Time Frame: Baseline and Week 26
Baseline and Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in HbA1c at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percentage of Participants Achieving HbA1c <5.7% at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Percentage of Participants Achieving HbA1c ≤6.5% at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Percentage of Participants Achieving HbA1c <7.0% at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Percent Change from Baseline in Body Weight at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Absolute (kg) Change from Baseline in Body Weight at Weeks 12 and 26
Time Frame: Baseline and 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
Time Frame: Baseline and 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
Time Frame: Baseline and 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
Time Frame: Baseline and 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
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Change from Baseline in Fasting Plasma Glucose at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Change from Baseline in Fasting Insulin at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Change from Baseline in Waist Circumference at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Change from Baseline in Hip Circumference at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Change from Baseline in Waist-to-Hip Ratio at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Change from Baseline in Waist-to-Height Ratio at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Change from Baseline in Body Mass Index (BMI) at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Change from Baseline in Total Cholesterol at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Change from Baseline in Triglycerides at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Change from Baseline in High Density Lipoprotein (HDL) Cholesterol at Weeks 12 and 26
Time Frame: Baseline and 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
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Change from Baseline in Apolipoprotein B at Weeks 12 and 26
Time Frame: Baseline and 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
Time Frame: Baseline and 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
Time Frame: Baseline and Weeks 12 and 26
Baseline and Weeks 12 and 26
Percentage of Participants with at Least One Treatment-Emergent Adverse Event
Time Frame: From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks)
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
Time Frame: From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks)
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
Time Frame: Baseline and Post-Baseline (up to 30 weeks)
Baseline and Post-Baseline (up to 30 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carmot Therapeutics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Carmot Therapeutics, Inc., a Member of the Roche Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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