A Study of Enicepatide (CT-388) in Participants With Obesity or Overweight With at Least One Weig… (NCT06525935) | Clinical Trial Compass
CompletedPhase 2
A Study of Enicepatide (CT-388) in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
United States469 participantsStarted 2024-08-16
Plain-language summary
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants with obesity or who are overweight with at least one weight-related comorbidity.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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/diag…
What they're measuring
1
Percent Change in Body Weight from Baseline to Week 48