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

NCT ID: NCT04838405

Last Updated: 2025-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-29

Study Completion Date

2024-08-02

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CT-388

SC dose of CT-388

Group Type EXPERIMENTAL

CT-388

Intervention Type DRUG

Synthetic Peptide

Placebo

SC dose of placebo matching CT-388 dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

CT-388 Optional

SC dose of CT-388

Group Type EXPERIMENTAL

CT-388

Intervention Type DRUG

Synthetic Peptide

CT-388 MD

SC dose of CT-388

Group Type EXPERIMENTAL

CT-388

Intervention Type DRUG

Synthetic Peptide

Interventions

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CT-388

Synthetic Peptide

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carmot Australia First Pty Ltd

INDUSTRY

Sponsor Role collaborator

Carmot Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Carmot Therapeutics, Inc.

Locations

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Carmot Clinical Research Unit 101

Perth, Western Australia, Australia

Site Status

Carmot Clinical Research Unit 105

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Australia Mexico

Related Links

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https://carmot-therapeutics.us/

Carmot Therapeutics, Inc.

Other Identifiers

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CT-388-101

Identifier Type: -

Identifier Source: org_study_id

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