A Study of Enicepatide (CT-388) in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

Conditions

• Obesity
• Overweight

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo will be volume- matched and administered subcutaneously (SC) once weekly.
• Enicepatide — DRUG
  Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.

Study Details

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.

Key Dates

Start date

Aug 16, 2024

Status verified

Apr 2026

Primary completion

Dec 8, 2025

Completion

Dec 8, 2025

Study Design

Enrollment

469 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Arm 1: Placebo
  Placebo administered subcutaneously (SC) once weekly.
• Experimental: Arm 2: Enicepatide Dose Level 1 (Low)
  Enicepatide Dose Level 1 administered SC once weekly.
• Experimental: Arm 3: Enicepatide Dose Level 2
  Enicepatide Dose Level 2 administered SC once weekly.
• Experimental: Arm 4: Enicepatide Dose Level 3
  Enicepatide Dose Level 3 administered SC once weekly.
• Experimental: Arm 5: Enicepatide Dose Level 4
  Enicepatide Dose Level 4 administered SC once weekly.
• Experimental: Arm 6: Enicepatide Dose Level 5 (High)
  Enicepatide Dose Level 5 administered SC once weekly.

Primary Outcome Measure

Percent Change in Body Weight from Baseline to Week 48 [ Time Frame: Baseline to Week 48 ]

Locations (34)

Find similar trials in Birmingham, AL

Related Studies

• Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
  PHASE2 · Recruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phoenix, Arizona
• Study to Investigate Genetic Causes of Severe Early Childhood Onset Obesity.
  Recruiting · Columbia University · Boston, Massachusetts
• Investigating the Impact of Obesity on Pubertal Development in Girls
  Recruiting · National Institute of Environmental Health Sciences (NIEHS) · Research Triangle Park, North Carolina
• Metabolic Effects of Angiotensin-(1-7)
  PHASE1 · Recruiting · Vanderbilt University · Nashville, Tennessee