A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Sponsor
Carmot Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05110846
Collaborator
(none)
96
6
3
12.2
16
1.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Feb 22, 2022
Anticipated Primary Completion Date
:
Feb 1, 2023
Anticipated Study Completion Date
:
Mar 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Placebo |
Drug: Placebo
Placebo
|
| Experimental: CT-868 Low Dose CT-868 |
Drug: CT-868
CT-868
|
| Experimental: CT-868 Maximum Tolerated Dose CT-868 |
Drug: CT-868
CT-868
|
Outcome Measures
Primary Outcome Measures
- Change in hemoglobin A1c (HbA1c) [Baseline up to 12 and 26 weeks]
Secondary Outcome Measures
- Change in mean body weight [Baseline up to 12 and 26 weeks]
- Fasting plasma glucose [Baseline up to 12 and 26 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carmot Clinical Center US01 | Los Angeles | California | United States | 90057 |
| 2 | Carmot Clinical Center MX04 | Guadalajara | Jalisco | Mexico | |
| 3 | Carmot Clinical Center MX01 | Monterrey | Nuevo Leon | Mexico | |
| 4 | Carmot Clinical Center MX02 | Monterrey | Nuevo Leon | Mexico | |
| 5 | Carmot Clinical Center MX05 | Mérida | Yucatan | Mexico | |
| 6 | Carmot Clinical Center MX03 | Mexico City | Mexico |
Sponsors and Collaborators
- Carmot Therapeutics, Inc.
Investigators
- Study Director: Michael Elliott, Carmot Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Carmot Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05110846
Other Study ID Numbers:
- CT-868-002
First Posted:
Nov 8, 2021
Last Update Posted:
Jul 26, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms: