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

Phase 1

• Conditions: Diabetes
• Interventions: Drug: CT-388; Drug: Placebo

• Registration Number: NCT04838405
• Lead Sponsor: Carmot Therapeutics, Inc.

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-24
• Last Update Posted: 2022-07-26
• Primary Completion: 2023-09
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

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

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Exclusion Criteria

• Significant medical history
• Uncontrolled hypertension
• History of malignancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CT-388	CT-388	SC dose of CT-388
Placebo	Placebo	SC dose of placebo matching CT-388 dose
CT-388 Optional	CT-388	SC dose of CT-388
CT-388 MD	CT-388	SC dose of CT-388

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events as assessed by self-report	Baseline up to 24 weeks	Safety and tolerability

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Carmot Clinical Research Unit 101; 🇦🇺 Perth, Western Australia, Australia

Carmot Clinical Research Unit 105; 🇲🇽 Monterrey, Nuevo Leon, Mexico