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Completed

NCT Number: NCT04838405

A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and 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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Carmot Clinical Research Unit 101, Perth, Western Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT-388

Drug

Synthetic Peptide

Placebo

Drug

Placebo

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events as assessed by self-report

    Time frame: Baseline up to 24 weeks

    Safety and tolerability

Secondary outcomes

  1. Area under the concentration versus time curve (AUC)

    Time frame: Baseline up to 24 weeks

    PK AUC

  2. Maximum observed drug concentration (Cmax)

    Time frame: Baseline up to 24 weeks

    PK Cmax

  3. Elimination half-life

    Time frame: Baseline up to 24 weeks

    PK t1/2

  4. Change in mean body weight

    Time frame: Baseline up to 24 weeks

    PD body weight

  5. Change in mean glucose levels

    Time frame: Baseline up to 24 weeks

    PD glucose

  6. Change in mean insulin levels

    Time frame: Baseline up to 24 weeks

    PD insulin

Sponsors and collaborators

Lead sponsor

Carmot Therapeutics, Inc.

Industry

Collaborators

  • Carmot Australia First Pty Ltd

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2021
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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