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

Primary Purpose

Diabetes

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CT-388
Placebo
Sponsored by
Carmot Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

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

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

Sites / Locations

  • Carmot Clinical Research Unit 102
  • Carmot Clinical Research Unit 101
  • Carmot Clinical Research Unit 105Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CT-388

Placebo

Arm Description

SC dose of CT-388

SC dose of placebo matching CT-388 dose

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events as assessed by self-report
Safety and tolerability

Secondary Outcome Measures

Area under the concentration versus time curve (AUC)
PK AUC
Maximum observe drug concentration (Cmax)
PK Cmax
Elimination half-life
PK t1/2
Change in mean body weight
PD body weight
Change in mean glucose levels
PD glucose
Change in mean insulin levels
PD insulin

Full Information

First Posted
April 5, 2021
Last Updated
July 24, 2022
Sponsor
Carmot Therapeutics, Inc.
Collaborators
Carmot Australia First Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04838405
Brief Title
A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT-388
Arm Type
Experimental
Arm Description
SC dose of CT-388
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
SC dose of placebo matching CT-388 dose
Intervention Type
Drug
Intervention Name(s)
CT-388
Intervention Description
Synthetic Peptide
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events as assessed by self-report
Description
Safety and tolerability
Time Frame
Baseline up to 6 weeks
Secondary Outcome Measure Information:
Title
Area under the concentration versus time curve (AUC)
Description
PK AUC
Time Frame
Baseline up to 6 weeks
Title
Maximum observe drug concentration (Cmax)
Description
PK Cmax
Time Frame
Baseline up to 6 weeks
Title
Elimination half-life
Description
PK t1/2
Time Frame
Baseline up to 6 weeks
Title
Change in mean body weight
Description
PD body weight
Time Frame
Baseline up to 6 weeks
Title
Change in mean glucose levels
Description
PD glucose
Time Frame
Baseline up to 6 weeks
Title
Change in mean insulin levels
Description
PD insulin
Time Frame
Baseline up to 6 weeks

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: 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
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 102
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Carmot Clinical Research Unit 101
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Carmot Clinical Research Unit 105
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
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

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

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