Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus

• Sponsor: Carmot Therapeutics, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05814107
• Collaborator: Carmot Australia First Pty Ltd (Other)
• Enrollment: 118
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.1
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

A study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with T2DM.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Overweight or Obesity	Drug: CT-996; Drug: Placebo	Phase 1

Detailed Description

A multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CT-996 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CT-996 Capsule of CT-996 intervention	Drug: CT-996; Capsule of CT-996
Placebo Comparator: Placebo Capsule of placebo matching CT-996 dose	Drug: Placebo; Capsule of Placebo

Outcome Measures

Primary Outcome Measures

1. Incidence of Treatment-Emergent Adverse Events in CT-996 participants [Baseline up to 28 days]

   To evaluate the safety and tolerability of CT-996

Secondary Outcome Measures

1. Maximum observe drug concentration (Cmax) of CT-996 [Baseline up to 28 days]

   PK Cmax

2. Effect of a High-Fat Meal on Plasma Concentration of CT-996 [Baseline up to 14 days]

   Determine the effect of a high-fat meal on the PK of CT-996 following a single dose

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participants 18-65 years old, inclusive

• BMI of 25 - 40, inclusive

• Stable body weight for two months

Exclusion Criteria:

• History of significant medical conditions and malignancy

• Uncontrollable hypertension

• History of alcoholism or drug addiction within 1 year prior to Screening

• Current or recent participation in an investigational clinical trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carmot Clinical Research Unit 101	Melbourne		Australia

Sponsors and Collaborators

• Carmot Therapeutics, Inc.
• Carmot Australia First Pty Ltd

Investigators

• Study Director: Michael Elliott, Carmot Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Carmot Therapeutics, Inc.

Publications

None provided.

• Responsible Party: Carmot Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05814107
• Other Study ID Numbers: CT-996-201
• First Posted: Apr 14, 2023
• Last Update Posted: Apr 14, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Carmot Therapeutics, Inc.: Type 2 Diabetes; Obesity; Overweight
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight

Study Results

No Results Posted as of Apr 14, 2023