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Anti-diabetic agent

CT-388 for Type 2 Diabetes and Obesity

Phase 2
Recruiting
Research Sponsored by Carmot Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Type 2 Diabetes Mellitus (T2DM) according to the World Health Organization classification or other locally applicable standards
Be older than 18 years old
Must not have
History of pancreatitis
Presence of active neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial will test a new drug called CT-388 at different doses to see if it is effective and safe for overweight or obese people with Type 2 diabetes.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of CT-388 aren't listed here, common ones for new diabetes medications can include nausea, low blood sugar levels (hypoglycemia), digestive issues like diarrhea or constipation, weight changes, urinary tract infections from increased urination if it affects kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type 2 Diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had pancreatitis before.
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I am currently experiencing symptoms of nerve damage.
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I have recently used injectable medication for high blood sugar.
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I have Type 1 Diabetes or another type, but not Type 2.
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I have recently taken medication for high blood sugar.
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My weight has significantly changed in the last 3 months.
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I have had or am planning to have surgery for weight loss.
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I have been diagnosed with major depressive disorder.
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I or my family have a history of medullary thyroid cancer.
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I have had or currently have certain eye conditions related to diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CT-388
2021
Completed Phase 1
~130

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheIndustry Sponsor
2,457 Previous Clinical Trials
1,097,352 Total Patients Enrolled
Carmot Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
946 Total Patients Enrolled
Clinical TrialsStudy DirectorCarmot Therapeutics, Inc., a Member of the Roche Group
2,227 Previous Clinical Trials
896,042 Total Patients Enrolled
~240 spots leftby May 2026
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