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Completed

NCT Number: NCT04973111

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

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.

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Key information

Conditions

Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Carmot Clinical Research Unit 101

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT-868 as SC Injection

Drug

CT-868

Placebo as SC Injection

Drug

Placebo

Active Comparator as SC Injection

Drug

Active Comparator

Primary outcomes

  1. Change in insulin secretion rate and ambient glucose levels

    Time frame: Baseline up to 4 days

Secondary outcomes

  1. Change in blood insulin levels at each level of glucose infusion

    Time frame: Baseline up to 4 days

  2. Change in blood glucose levels at each level of glucose infusion

    Time frame: Baseline up to 4 days

Sponsors and collaborators

Lead sponsor

Carmot Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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