Status:
COMPLETED
A Study of CT-388 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
Lead Sponsor:
Carmot Therapeutics, Inc.
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- Male or female, 18 to 75 years of age
- Body mass index (BMI) ≥30.0 kg/m2, OR BMI ≥27.0 and \<30.0 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities, such as: prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
- At least one self-reported unsuccessful effort to lose body weight
Exclusion
- 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
- Self-reported body weight change of \>5 kg within 3 months before randomization
- Any unbalanced/extreme diets within 3 months of the screening visit, or plan to be on such diets during the study
- Current or recent participation in an organized weight reduction program
- Current or recent use of any treatment that promotes weight loss or glucose metabolism
- Current or recent use of treatment that may cause weight gain
- Prior or planned surgical treatment for obesity
- Clinically significant or active gastric emptying abnormality, malabsorption, or chronic use of medications that directly affect GI motility
- History of chronic pancreatitis or acute pancreatitis within 6 months before screening
- Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
- History of major depressive disorder within 2 years of screening, or any history/diagnosis of other severe psychiatric conditions (Note: Prospective participants with depression or anxiety whose disease state, in the opinion of the Investigator, is considered stable and expected to remain stable throughout the course of the study, may be considered for inclusion)
- Family or personal history of medullary thyroid carcinoma
- Serum calcitonin ≥ 20 ng/L
- Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method
Key Trial Info
Start Date :
August 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2025
Estimated Enrollment :
469 Patients enrolled
Trial Details
Trial ID
NCT06525935
Start Date
August 16 2024
End Date
December 8 2025
Last Update
January 8 2026
Active Locations (34)
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1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
Central Alabama Research
Homewood, Alabama, United States, 35209
3
The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health
Mesa, Arizona, United States, 85210
4
Amicis Research Center - Anaheim
Anaheim, California, United States, 92801