A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes (Enith2)

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 and 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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus; Obesity or Overweight
• Intervention / Treatment: Combination product: Placebo; Combination product: Enicepatide

• Study Type: Interventional
• Enrollment (Estimated): 1600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: WC45726 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com
• Study Contact Backup: Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1405BCH
    • Recruiting
    • IME - Instituto Médico Especializado
  • Buenos Aires, Argentina, C1056ABI
    • Recruiting
    • CINME
  • Buenos Aires, Argentina, C1060ABN
    • Recruiting
    • CEDIC Centro de Investigaciones Clinicas
  • Buenos Aires, Argentina, C1120AAC
    • Recruiting
    • Centro Médico Viamonte SRL
  • Ciudad Autonoma Buenos Aires, Argentina, C1425AGC
    • Recruiting
    • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
  • Ciudad Autonoma Buenos Aires, Argentina, C1204AAD
    • Recruiting
    • Instituto Centenario
  • Mar del Plata, Argentina, B7600FYK
    • Recruiting
    • Centro de Investigaciones Medicas Mar del Plata
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Recruiting
      • Paratus Clinical Western Sydney
  • Queensland
    • Meadowbrook, Queensland, Australia, 4131
      • Recruiting
      • Logan Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Baker Heart and Diabetes Insitute
• Canada
  • Québec, Canada, G1V 4W2
    • Recruiting
    • Clinique des maladies lipidiques de Quebec
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Y 3W2
      • Recruiting
      • TGElliott Inc. dba BC Diabetes
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • Recruiting
      • Centricity Research Brampton Endocrinology
    • Greater Sudbury, Ontario, Canada, P3C 1X3
      • Recruiting
      • Medicor Research Inc
    • Toronto, Ontario, Canada, M4G 3E8
      • Recruiting
      • LMC Clinical Research Inc
• Japan
  • Aichi, Japan, 486-8510
    • Recruiting
    • Kasugai Municipal Hospital
  • Fukuoka, Japan, 810-0066
    • Recruiting
    • Fukuhama Chuo Clinic
  • 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
• Puerto Rico
  • San Juan, Puerto Rico, 00927
    • Recruiting
    • FDI Clinical Research
• 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
• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Siriraj Hospital
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Division of Endocrinology and Metabolism;Internal Medicine
  • Hat Yai, Thailand, 90110
    • Recruiting
    • Songklanagarind Hospital
  • Khlong Luang, Thailand, 12120
    • Recruiting
    • Thammasat University Hospital
• United States
  • Alabama
    • Guntersville, Alabama, United States, 35976
      • Recruiting
      • Lakeview Clinical Research
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Recruiting
      • Arizona Clinical Trials
  • California
    • Lake Forest, California, United States, 92630
      • Recruiting
      • Orange County Research Center
    • Long Beach, California, United States, 90815
      • Recruiting
      • ARK Clinical Research
    • Montclair, California, United States, 91763
      • Recruiting
      • Catalina Research Institute, LLC
    • Rancho Cucamonga, California, United States, 91730
      • Recruiting
      • Prospective Research Innovations Inc.
    • Spring Valley, California, United States, 91978
      • Recruiting
      • Encompass Clinical Research
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20009
      • Recruiting
      • Emerson Clinical Research Institute
  • Florida
    • Clearwater, Florida, United States, 33761
      • Recruiting
      • Tampa Bay Medical Research, Inc.
    • Pembroke Pines, Florida, United States, 33024
      • Recruiting
      • Center for Diabetes, Obesity and Metabolism Inc
    • Port Orange, Florida, United States, 32127
      • Recruiting
      • Progressive Medical Research
    • St. Petersburg, Florida, United States, 33711
      • Recruiting
      • Eirvera, LLC
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Recruiting
      • Centricity Research Columbus Georgia Multispecialty
    • Union City, Georgia, United States, 30291
      • Recruiting
      • Rophe Adult and Pediatric Medicine/SKYCRNG
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Recruiting
      • Elevate Clinical Research
  • Maryland
    • Columbia, Maryland, United States, 21045-5840
      • Recruiting
      • Centennial Medical Group
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Recruiting
      • Centricity Research Morehead City Multispeciality
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Recruiting
      • Remington Davis Inc
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74137
      • Recruiting
      • Essential Medical Research
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Recruiting
      • Coastal Carolina Research Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Recruiting
      • Circle Clinical Research
  • Texas
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Velocity Clinical Research
    • Houston, Texas, United States, 77040
      • Recruiting
      • Juno Research, LLC
    • Pasadena, Texas, United States, 77505
      • Recruiting
      • HRI ? Pasadena, LLC
    • Tomball, Texas, United States, 77375
      • Recruiting
      • DM Clinical Research
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Recruiting
      • Manassas Clinical Research Center
    • Suffolk, Virginia, United States, 23435
      • Recruiting
      • Centricity Research Suffolk Primary Care
  • Washington
    • Redmond, Washington, United States, 98052
      • Recruiting
      • Era Health Research

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
• Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
• Body mass index (BMI) ≥27.0 kg/m^2
• History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

Exclusion Criteria:

• History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
• Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
• At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
• 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)
• Poorly controlled hypertension at screening
• Have 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
• 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 Hemoglobin A1c (HbA1c) at Week 72	Baseline through Week 72
Percentage of Participants Achieving HbA1c of ≤6.5% at Week 72	Week 72
Percentage of Participants Achieving HbA1c of <7% at Week 72	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 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 IWQoL-Lite-CT Domain Scores and Total Score at Week 72	Baseline through Week 72
Change from Baseline in Non-HDL Cholesterol at Week 72	Baseline through Week 72
Change from Baseline in VLDL 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 High-Sensitivity C-reactive Protein (hsCRP) at Week 72	Baseline through Week 72
Change from Baseline in Urinary Albumin/Creatinine Ratio 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
Time to Achieve ≥5%, ≥10%, or ≥15% Body Weight Loss from Baseline Through Week 72	From Baseline through Week 72
Percentage of Participants Achieving HbA1c of <5.7% at Week 72	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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2026
• Primary Completion (Estimated): August 7, 2028
• Study Completion (Estimated): August 7, 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): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2
• Other Study ID Numbers: WC45726; 2025-523106-32-00 (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