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

Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04838405
• Other study ID #: CT-388-101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 1, 2021
• Est. completion date: October 2023

Study information

• Verified date: July 2022
• Source: Carmot Therapeutics, Inc.
• Contact: Michael Elliott
• Phone: 510-666-6328
• Email: melliott[@]carmot.us
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Overweight

Intervention

Drug:
• CT-388
Synthetic Peptide
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	Carmot Clinical Research Unit 102	Adelaide	South Australia
Australia	Carmot Clinical Research Unit 101	Perth	Western Australia
Mexico	Carmot Clinical Research Unit 105	Monterrey	Nuevo Leon

Sponsors (2)

Lead Sponsor	Collaborator
Carmot Therapeutics, Inc.	Carmot Australia First Pty Ltd

Countries where clinical trial is conducted

Australia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events as assessed by self-report	Safety and tolerability	Baseline up to 6 weeks
Secondary	Area under the concentration versus time curve (AUC)	PK AUC	Baseline up to 6 weeks
Secondary	Maximum observe drug concentration (Cmax)	PK Cmax	Baseline up to 6 weeks
Secondary	Elimination half-life	PK t1/2	Baseline up to 6 weeks
Secondary	Change in mean body weight	PD body weight	Baseline up to 6 weeks
Secondary	Change in mean glucose levels	PD glucose	Baseline up to 6 weeks
Secondary	Change in mean insulin levels	PD insulin	Baseline up to 6 weeks

External Links

•   Carmot Therapeutics, Inc.