CT-388 for Type 2 Diabetes and Obesity

Recruiting at 57 trial locations

Overseen By Reference Study ID: CT-388-104 Roche Study ID: XC45544

Age: 18+

Sex: Any

Trial Phase: Phase 2

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 This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

360 Participants Needed

Trial Summary

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.

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).

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%

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.

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

Trial Overview The 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

Group I: Arm 5: CT-388 Dose Level 4 (High) Experimental Treatment 1 Intervention

Group II: Arm 4: CT-388 Dose Level 3 Experimental Treatment 1 Intervention

Group III: Arm 3: CT-388 Dose Level 2 Experimental Treatment 1 Intervention

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

Group V: Arm 1: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Carmot Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

1,300+

Hoffmann-La Roche

Industry Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University