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

Primary Purpose

Type 2 Diabetes, Overweight or Obesity

Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
CT-996
Placebo
Sponsored by
Carmot Australia First Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Obesity, Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Carmot Clinical Research Unit 101Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CT-996

Placebo

Arm Description

Capsule of CT-996 intervention

Capsule of placebo matching CT-996 dose

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events in CT-996 participants
To evaluate the safety and tolerability of CT-996

Secondary Outcome Measures

Maximum observe drug concentration (Cmax) of CT-996
PK Cmax
Effect of a High-Fat Meal on Plasma Concentration of CT-996
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose

Full Information

First Posted
February 23, 2023
Last Updated
June 14, 2023
Sponsor
Carmot Australia First Pty Ltd
Collaborators
Carmot Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05814107
Brief Title
Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carmot Australia First Pty Ltd
Collaborators
Carmot Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Overweight or Obesity
Keywords
Type 2 Diabetes, Obesity, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT-996
Arm Type
Experimental
Arm Description
Capsule of CT-996 intervention
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsule of placebo matching CT-996 dose
Intervention Type
Drug
Intervention Name(s)
CT-996
Intervention Description
Capsule of CT-996
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule of Placebo
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events in CT-996 participants
Description
To evaluate the safety and tolerability of CT-996
Time Frame
Baseline up to 28 days
Secondary Outcome Measure Information:
Title
Maximum observe drug concentration (Cmax) of CT-996
Description
PK Cmax
Time Frame
Baseline up to 28 days
Title
Effect of a High-Fat Meal on Plasma Concentration of CT-996
Description
Determine the effect of a high-fat meal on the PK of CT-996 following a single dose
Time Frame
Baseline up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Elliott
Phone
510-666-6328
Email
melliott@carmot.us
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Elliott
Organizational Affiliation
Carmot Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Carmot Clinical Research Unit 101
City
Melbourne
Country
Australia
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://carmot-therapeutics.us/
Description
Carmot Therapeutics, Inc.

Learn more about this trial

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

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