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

Carmot Therapeutics

Status and phase: Completed; Phase 1

Conditions: Diabetes

Treatments: Drug: CT-868 as SC Injection; Drug: Placebo as SC Injection; Drug: Active Comparator as SC Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04973111

CT-868-003

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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32 participants in 3 patient groups, including a placebo group

CT-868

Experimental group

Description:

SC dose of CT-868 Intervention: Drug: CT-868

Treatment:

Drug: CT-868 as SC Injection

Placebo

Placebo Comparator group

Description:

SC dose of placebo matching CT-868 dose Intervention: Drug: Placebo

Treatment:

Drug: Placebo as SC Injection

Active Comparator

Active Comparator group

Description:

SC dose of Active Comparator Intervention: Drug: Active Comparator

Treatment:

Drug: Active Comparator as SC Injection