A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus

October 15, 2025 updated by: Carmot Therapeutics, Inc.

A Phase 1 Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-388 in Otherwise Healthy Overweight and Obese Adult Participants and in Obese Patients With Type 2 Diabetes Mellitus

This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult participants and obese participants with T2DM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 1

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

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Carmot Clinical Research Unit 101
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66260
        • Carmot Clinical Research Unit 105

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Males or females
  • 18-65 years old, inclusive
  • BMI 27.0-40.0, inclusive
  • Stable body weight for 2 months

Exclusion Criteria:

  • Significant medical history
  • Uncontrolled hypertension
  • 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: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT-388
SC dose of CT-388
Drug: CT-388
Synthetic Peptide
Placebo Comparator: Placebo
SC dose of placebo matching CT-388 dose
Drug: Placebo
Placebo
Experimental: CT-388 Optional
SC dose of CT-388
Drug: CT-388
Synthetic Peptide
Experimental: CT-388 MD
SC dose of CT-388
Drug: CT-388
Synthetic Peptide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events as assessed by self-report
Time Frame: Baseline up to 24 weeks
Safety and tolerability
Baseline up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the concentration versus time curve (AUC)
Time Frame: Baseline up to 24 weeks
PK AUC
Baseline up to 24 weeks
Elimination half-life
Time Frame: Baseline up to 24 weeks
PK t1/2
Baseline up to 24 weeks
Change in mean body weight
Time Frame: Baseline up to 24 weeks
PD body weight
Baseline up to 24 weeks
Change in mean glucose levels
Time Frame: Baseline up to 24 weeks
PD glucose
Baseline up to 24 weeks
Change in mean insulin levels
Time Frame: Baseline up to 24 weeks
PD insulin
Baseline up to 24 weeks
Maximum observed drug concentration (Cmax)
Time Frame: Baseline up to 24 weeks
PK Cmax
Baseline up to 24 weeks

Collaborators and Investigators

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

Sponsor

Carmot Therapeutics, Inc.

Collaborators

Carmot Australia First Pty Ltd

Investigators

  • Study Director: Clinical Trials, Carmot Therapeutics, Inc.

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)

April 29, 2021

Primary Completion (Actual)

June 18, 2024

Study Completion (Actual)

August 2, 2024

Study Registration Dates

First Submitted

April 5, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 15, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-388-101

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

No

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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