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A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus

Primary Purpose

Obesity, Type2 Diabetes

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
CT-868
Sponsored by
Carmot Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or Females with T2DM
  • BMI of ≥27 kg/m2, inclusive
  • 18-75 years old, inclusive
  • Stable body weight for 3 months

Exclusion Criteria:

  • Significant medical history
  • Uncontrolled diabetes
  • History of malignancy

Sites / Locations

  • Carmot Clinical Center US01
  • Carmot Clinical Center MX04
  • Carmot Clinical Center MX01
  • Carmot Clinical Center MX02
  • Carmot Clinical Center MX05
  • Carmot Clinical Center MX03

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

CT-868 Low Dose

CT-868 Maximum Tolerated Dose

Arm Description

Placebo

CT-868

CT-868

Outcomes

Primary Outcome Measures

Change in hemoglobin A1c (HbA1c)

Secondary Outcome Measures

Change in mean body weight
Fasting plasma glucose

Full Information

First Posted
November 4, 2021
Last Updated
July 24, 2022
Sponsor
Carmot Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05110846
Brief Title
A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Center Study to Evaluate the Efficacy, Safety, and Tolerability of CT-868 Administered for 26 Weeks to Overweight and Obese Participants With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carmot Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Study to Assess the effect of CT-868 in hemoglobin A1c (HbA1c) in Overweight and Obese Participants with Type 2 Diabetes Mellitus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
CT-868 Low Dose
Arm Type
Experimental
Arm Description
CT-868
Arm Title
CT-868 Maximum Tolerated Dose
Arm Type
Experimental
Arm Description
CT-868
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
CT-868
Intervention Description
CT-868
Primary Outcome Measure Information:
Title
Change in hemoglobin A1c (HbA1c)
Time Frame
Baseline up to 12 and 26 weeks
Secondary Outcome Measure Information:
Title
Change in mean body weight
Time Frame
Baseline up to 12 and 26 weeks
Title
Fasting plasma glucose
Time Frame
Baseline up to 12 and 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or Females with T2DM BMI of ≥27 kg/m2, inclusive 18-75 years old, inclusive Stable body weight for 3 months Exclusion Criteria: Significant medical history Uncontrolled diabetes History of malignancy
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 Center US01
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Carmot Clinical Center MX04
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Carmot Clinical Center MX01
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Carmot Clinical Center MX02
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Carmot Clinical Center MX05
City
Mérida
State/Province
Yucatan
Country
Mexico
Facility Name
Carmot Clinical Center MX03
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

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

Learn more about this trial

A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus

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