A Study to Assess CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose.

April 30, 2022 updated by: Carmot Therapeutics, Inc.

A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess Pharmacokinetic and Pharmacodynamic Effects of CT-868 on the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects With T2DM

A Study to Assess the Effect of CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Carmot Clinical Research Unit 101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Part 1: Obese Otherwise Healthy Males
  • Part 2: Males or Females with T2D
  • Part 1: BMI 30.0-35.0, inclusive
  • Part 2: BMI 27.0-45.0, inclusive
  • 18-65 years old, inclusive
  • Stable body weight for 2 months

Exclusion Criteria:

  • Significant medical history
  • Uncontrolled hypertension
  • History of malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT-868
SC dose of CT-868 Intervention: Drug: CT-868
Drug: CT-868 as SC Injection
CT-868
Placebo Comparator: Placebo
SC dose of placebo matching CT-868 dose Intervention: Drug: Placebo
Drug: Placebo as SC Injection
Placebo
Active Comparator: Active Comparator
SC dose of Active Comparator Intervention: Drug: Active Comparator
Drug: Active Comparator as SC Injection
Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in insulin secretion rate and ambient glucose levels
Time Frame: Baseline up to 4 days
Baseline up to 4 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in blood insulin levels at each level of glucose infusion
Time Frame: Baseline up to 4 days
Baseline up to 4 days
Change in blood glucose levels at each level of glucose infusion
Time Frame: Baseline up to 4 days
Baseline up to 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmot Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2021

Primary Completion (Actual)

April 22, 2022

Study Completion (Actual)

April 22, 2022

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 30, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CT-868-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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