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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Prior history/diagnosis/lab evidence of any type of diabetes mellitus (e.g., Type 1, Type 2, gestational), or a history of ketoacidosis or hyperosmolar state
Current or recent use of any treatment that promotes weight loss or glucose metabolism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing a new drug called CT-388 at different doses to see how well it works and if it is safe. It is being conducted at multiple locations with some participants receiving the drug and
Who is the study for?
This trial is for adults aged 18-75 with obesity (BMI ≥30) or overweight (BMI ≥27) with weight-related health issues like prediabetes, high blood pressure, or heart disease. Participants should have tried to lose weight before without success and must not be on extreme diets, any diabetes medication, recent weight loss programs or treatments that affect body weight.
What is being tested?
The study tests the effectiveness and safety of a new drug called CT-388 in three different doses compared to a placebo. It's designed as a multi-center test where participants are randomly assigned to either the drug or placebo group without knowing which one they receive.
What are the potential side effects?
While specific side effects of CT-388 aren't listed here, common ones for obesity treatments can include digestive issues, changes in taste or appetite, fatigue, headache, and sometimes more serious conditions related to metabolism.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with or have had diabetes.
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I am currently using or have recently used weight loss or diabetes medication.
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I have had or am planning to have surgery for weight loss.
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I have a significant stomach emptying issue, malabsorption, or use meds that affect my stomach's movement.
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My obesity is caused by a hormonal disorder or a genetic condition.
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I or my family have a history of medullary thyroid cancer.
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I am not pregnant, breastfeeding, planning to become pregnant, or if of childbearing potential, I am using effective contraception.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 6: CT-388 Dose Level 5 (High)Experimental Treatment1 Intervention
CT-388 Dose Level 5 administered SC once weekly.
Group II: Arm 5: CT-388 Dose Level 4Experimental Treatment1 Intervention
CT-388 Dose Level 4 administered SC once weekly.
Group III: Arm 4: CT-388 Dose Level 3Experimental Treatment1 Intervention
CT-388 Dose Level 3 administered SC once weekly.
Group IV: Arm 3: CT-388 Dose Level 2Experimental Treatment1 Intervention
CT-388 Dose Level 2 administered SC once weekly.
Group V: Arm 2: CT-388 Dose Level 1 (Low)Experimental Treatment1 Intervention
CT-388 Dose Level 1 administered SC once weekly.
Group VI: Arm 1: PlaceboPlacebo Group1 Intervention
Placebo administered subcutaneously (SC) once weekly.
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Who is running the clinical trial?
Carmot Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
462 Total Patients Enrolled
1 Trials studying Obesity
96 Patients Enrolled for Obesity
Hoffmann-La RocheIndustry Sponsor
2,444 Previous Clinical Trials
1,092,672 Total Patients Enrolled
7 Trials studying Obesity
455 Patients Enrolled for Obesity
Clinical TrialsStudy DirectorCarmot Therapeutics, Inc., a Member of the Roche Group
2,212 Previous Clinical Trials
891,966 Total Patients Enrolled
2 Trials studying Obesity
110 Patients Enrolled for Obesity
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