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

Carmot Therapeutics

Status and phase: Completed; Phase 1

Conditions: Diabetes

Treatments: Drug: CT-388; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04838405

CT-388-101

Details and patient eligibility

About

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.

Enrollment: 129 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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129 participants in 4 patient groups, including a placebo group

CT-388

Experimental group

Description:

SC dose of CT-388

Treatment:

Drug: CT-388

Placebo

Placebo Comparator group

Description:

SC dose of placebo matching CT-388 dose

Treatment:

Drug: Placebo

CT-388 Optional

Experimental group

Description:

SC dose of CT-388

Treatment:

Drug: CT-388

CT-388 MD

Experimental group

Description:

SC dose of CT-388

Treatment:

Drug: CT-388