A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes (Enith1)

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

Study Overview

• Status: Recruiting
• Conditions: Obesity or Overweight
• Intervention / Treatment: Combination product: Placebo; Combination product: Enicepatide

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: WC45725 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1056ABI
    • Recruiting
    • CINME
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Recruiting
      • Paratus Clinical Western Sydney
• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Recruiting
      • Aggarwal and Associates
    • Hamilton, Ontario, Canada, L8L 5G8
      • Recruiting
      • Wharton Medical Clinic
• Japan
  • Aichi, Japan, 486-8510
    • Recruiting
    • Kasugai Municipal Hospital
  • Hokkaido, Japan, 066-0032
    • Recruiting
    • Hasegawa Medicine Clinic
  • Hokkaido, Japan, 060-0061
    • Recruiting
    • NTT Medical Center Sapporo
  • Tokyo, Japan, 114-0001
    • Recruiting
    • Higashijujo Sakai Diabetes Internal Medicine Clinic
• Taiwan
  • Changhua, Taiwan, 50006
    • Recruiting
    • Changhua Christian Hospital
  • Chiayi City, Taiwan, 600
    • Recruiting
    • Chia-Yi Christian Hospital
  • Kaohsiung City, Taiwan, 80756
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40201
    • Recruiting
    • Chung Shan Medical University Hospital
  • Taichung, Taiwan, 40447
    • Recruiting
    • China Medical University Hospital
  • Tainan, Taiwan, 70403
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10048
    • Recruiting
    • National Taiwan University Hospital
  • Taipei, Taiwan, 112
    • Recruiting
    • Taipei Veterans General Hospital
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Recruiting
      • Pinnacle Research Group
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Recruiting
      • Arizona Clinical Trials
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Artemis Institute for Clinical Research, LLC
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Recruiting
      • Elevate Clinical Research
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Recruiting
      • Monroe Biomedical Research
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Recruiting
      • International Diabetes Center At Park Nicollet
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Recruiting
      • Clinvest Research LLC
  • Oregon
    • Portland, Oregon, United States, 97210
      • Recruiting
      • Headlands Reseach- Summit
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Trial Management Associates
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Clinical Research Associates
  • Texas
    • Houston, Texas, United States, 77058
      • Recruiting
      • Elevate Clinical
    • McAllen, Texas, United States, 78504
      • Recruiting
      • Elevate Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must have at screening:

  1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m^2; or
  2. BMI ≥27.0 kg/m^2 and <30.0 kg/m^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease
• History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
• Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)

Exclusion Criteria:

• History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
• Self-reported change in body weight >5 kg within 3 months prior to screening
• Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
• Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
• Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
• History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
• Poorly controlled hypertension at screening
• Any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure.
• Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.
• Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 1: Placebo	Combination product: Placebo; Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
Experimental: Arm 2: Enicepatide Dosing Regimen 1	Combination product: Enicepatide; Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.; Other Names: RO7795068; RG6640; CT-388
Experimental: Arm 3: Enicepatide Dosing Regimen 2	Combination product: Enicepatide; Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.; Other Names: RO7795068; RG6640; CT-388
Experimental: Arm 4: Enicepatide Dosing Regimen 3	Combination product: Enicepatide; Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.; Other Names: RO7795068; RG6640; CT-388

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent (%) Change from Baseline in Body Weight at Week 72	Baseline through Week 72

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72	Baseline and Week 72
Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72	Baseline and Week 72
Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72	Baseline and Week 72
Change from Baseline in Body Weight (kg) at Week 72	Baseline through Week 72
Change from Baseline in Waist Circumference (cm) at Week 72	Baseline through Week 72
Change from Baseline in Fasting Glucose at Week 72	Baseline through Week 72
Change from Baseline in Fasting Insulin at Week 72	Baseline through Week 72
Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 72	Baseline through Week 72
Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72	Baseline through Week 72
Change from Baseline in Triglyceride at Week 72	Baseline through Week 72
Change from Baseline in Systolic Blood Pressure at Week 72	Baseline through Week 72
Change from Baseline in the Physical Functioning Domain Score of the Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form at Week 72	Baseline through Week 72
Change from Baseline in Physical Functioning Composite Score of the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 72	Baseline through Week 72
Change from Baseline in Waist-to-Hip Ratio at Week 72	Baseline through Week 72
Change from Baseline in Waist-to-Height Ratio at Week 72	Baseline through Week 72
Change from Baseline in Subscale Scores of the Control of Eating Questionnaire (CoEQ) at Week 72	Baseline through Week 72
Change from Baseline in Symptoms and Impact of Urinary Incontinence as Assessed by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at Week 72	Baseline through Week 72
Percentage of Participants Experiencing No Change, Improvement, or Worsening on the Patient Global Impression of Change (PGI-C) Urinary Incontinence Questionnaire at Week 72	Baseline and Week 72
Percentage of Participants Experiencing No Change, Improvement, or Worsening on the Patient Global Impression of Severity (PGI-S) Urinary Incontinence Questionnaire at Week 72	Baseline and Week 72
Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-C Physical Functioning Questionnaire at Week 72	Baseline and Week 72
Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-S Physical Functioning Questionnaire at Week 72	Baseline and Week 72
Change from Baseline in Non-HDL Cholesterol at Week 72	Baseline through Week 72
Change from Baseline in Total Cholesterol at Week 72	Baseline through Week 72
Change from Baseline in Free Fatty Acids at Week 72	Baseline through Week 72
Change from Baseline in Diastolic Blood Pressure at Week 72	Baseline through Week 72
Change from Baseline in Body Mass Index (BMI) at Week 72	Baseline through Week 72
Percent (%) Change from Baseline in Body Weight by Obesity Class at Week 72	Baseline through Week 72
Incidence and Severity of Adverse Events, with Severity Determined According to Mild/Moderate/Severe Criteria	Baseline through Week 72
Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score Through Week 72	Baseline through Week 72
Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score Through Week 72	Baseline through Week 72
Percentage of Participants Achieving ≥20% Body Weight Loss from Baseline at Week 72	Baseline and Week 72
Percentage of Participants Achieving ≥25% Body Weight Loss from Baseline at Week 72	Baseline and Week 72
Percentage of Participants Achieving Normoglycemia (HbA1c <5.7%) at Week 72	Baseline and Week 72
Change from Baseline in Health Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Form Domain Scores and Component Summary Scores at Week 72	Baseline through Week 72
Change from Baseline in HRQoL as Assessed by the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire Domain Scores and Total Score at Week 72	Baseline through Week 72
Change from Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 72	Baseline through Week 72
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 72	Baseline through Week 72
Percentage of Participants Achieving ≥30% Body Weight Loss from Baseline at Week 72	Baseline and Week 72
Time to Achieve ≥5%, ≥10%, ≥15%, ≥20%, ≥25%, ≥30% Body Weight Loss from Baseline Through Week 72	From Baseline through Week 72
Change from Baseline in Total Lean Tissue Volume (Litres) at Week 72, as Assessed by Magnetic Resonance Imaging (MRI)	Baseline through Week 72
Percent (%) Change from Baseline in Total Lean Tissue Volume at Week 72, as Assessed by MRI	Baseline through Week 72
Change from Baseline in Total Adipose Tissue Volume (Litres) at Week 72, as Assessed by MRI	Baseline through Week 72
Percent (%) Change from Baseline in Total Adipose Tissue Volume at Week 72, as Assessed by MRI	Baseline through Week 72

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): July 24, 2028
• Study Completion (Estimated): August 28, 2028

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: WC45725; 2025-523104-71-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No