CT-388 for Type 2 Diabetes and Obesity

Recruiting in Palo Alto (17 mi)

+43 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Carmot Therapeutics, Inc.

Must be taking: Metformin, SGLT-2 inhibitors

Must not be taking: Oral antihyperglycemics, Injectable antihyperglycemics

Disqualifiers: Type 1 diabetes, Retinopathy, Neuropathy, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).

Will I have to stop taking my current medications?

You can continue taking metformin or SGLT-2 inhibitors for managing Type 2 diabetes, but you cannot take other oral or injectable diabetes medications during the study.

Research Team

Clinical Trials

Principal Investigator

Carmot Therapeutics, Inc., a Member of the Roche Group

Eligibility Criteria

This trial is for adults aged 18-75 who are overweight or obese with Type 2 diabetes. They should have tried diet and exercise without success, have an HbA1c level between 7% and 10.5%, and a BMI of at least 25 kg/m^2. Participants may be managing their diabetes with diet, exercise, metformin, or SGLT-2 inhibitors.

Inclusion Criteria

Body mass index (BMI) ≥25.0 kg/m^2

At least one self-reported unsuccessful diet/exercise effort to lose body weight

HbA1c ≥7% and ≤10.5%

See 3 more

Exclusion Criteria

I have had pancreatitis before.

I am currently experiencing symptoms of nerve damage.

I have Type 1 Diabetes or another type, but not Type 2.

See 14 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-weekly subcutaneous administration of CT-388 or placebo for 48 weeks

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

CT-388 (Anti-diabetic agent)

Trial OverviewThe study tests the effectiveness and safety of CT-388 in three different doses compared to a placebo in controlling blood sugar levels for those with obesity and Type 2 diabetes. It's randomized (participants are put into groups by chance), double-blind (neither participants nor researchers know who gets what treatment), and placebo-controlled.

Participant Groups

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 5: CT-388 Dose Level 4 (High)Experimental Treatment1 Intervention

Group II: Arm 4: CT-388 Dose Level 3Experimental Treatment1 Intervention

Group III: Arm 3: CT-388 Dose Level 2Experimental Treatment1 Intervention

Group IV: Arm 2: CT-388 Dose Level 1 (Low)Experimental Treatment1 Intervention

Group V: Arm 1: PlaceboPlacebo Group1 Intervention