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

Phase 1

Completed

• Conditions: Diabetes
• Interventions: Drug: CT-868 as SC Injection; Drug: Placebo as SC Injection; Drug: Active Comparator as SC Injection

• Registration Number: NCT04973111
• Lead Sponsor: Carmot Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-07-12
• Study First Submitted: 2021-07-14
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-22
• Status Verified: 2022-04
• Primary Completion: 2022-04-22
• Study Completion: 2022-04-22
• Last Update Submitted: 2022-04-30
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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Exclusion Criteria

• Significant medical history
• Uncontrolled hypertension
• History of malignancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CT-868	CT-868 as SC Injection	SC dose of CT-868 Intervention: Drug: CT-868
Placebo	Placebo as SC Injection	SC dose of placebo matching CT-868 dose Intervention: Drug: Placebo
Active Comparator	Active Comparator as SC Injection	SC dose of Active Comparator Intervention: Drug: Active Comparator

Primary Outcome Measures

Name	Time	Method
Change in insulin secretion rate and ambient glucose levels	Baseline up to 4 days

Secondary Outcome Measures

Name	Time	Method
Change in blood insulin levels at each level of glucose infusion	Baseline up to 4 days
Change in blood glucose levels at each level of glucose infusion	Baseline up to 4 days

Trial Locations

Locations (1)

Carmot Clinical Research Unit 101; 🇺🇸 Chula Vista, California, United States