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/ No attachments to email below.; 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. 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
  • South Australia
    • Oaklands Park, South Australia, Australia, 5046
      • Recruiting
      • Southern Adelaide Diabetes and Endocrine Services (SADES)
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Baker Heart and Diabetes Insitute
• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven Gasthuisberg
• Canada
  • Québec, Canada, G2J0C4
    • Recruiting
    • Alpha Recherche Clinique
  • Alberta
    • Calgary, Alberta, Canada, T2V 4J2
      • Recruiting
      • C-health Partners Inc
  • British Columbia
    • Surrey, British Columbia, Canada, V3T 4G8
      • Recruiting
      • Unity Healthcare Clinic
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Recruiting
      • Aggarwal and Associates
    • Hamilton, Ontario, Canada, L8L 5G8
      • Recruiting
      • Wharton Medical Clinic
    • Hamilton, Ontario, Canada, L8L 5G4
      • Recruiting
      • Hamilton Medical Research Group
    • Sarnia, Ontario, Canada, N7T 4X3
      • Recruiting
      • Bluewater Clinical Research Group
  • Quebec
    • Trois-Rivières, Quebec, Canada, G9A 4P3
      • Recruiting
      • Diex Recherche Trois-Rivieres
• China
  • Beijing, China, 100044
    • Recruiting
    • Peking University People's Hospital
  • Beijing, China, 101200
    • Recruiting
    • Beijing Pinggu Hospital
  • Hefei, China, 230011
    • Recruiting
    • The Second People's Hospital of Hefei
  • Huizhou, China, 516001
    • Recruiting
    • Huizhou Central People's Hospital
  • Nanjing, China, 210003
    • Recruiting
    • The Second Affiliated Hospital of Nanjing Medical University
  • Shanghai, China, 201299
    • Recruiting
    • Shanghai Pudong New Area People's Hospital
  • Shaanxi
    • Xianyang, Shaanxi, China, 712000
      • Recruiting
      • Yan'an University Xianyang Hospital
• Czechia
  • Náchod, Czechia, 54701
    • Recruiting
    • Edumed s.r.o.;Diabetologická ambulance
  • Plze?, Czechia, 301 00
    • Recruiting
    • DIALINE s.r.o.
  • Prague, Czechia, 140 00
    • Recruiting
    • DiaVize
  • Prague, Czechia, 140 00
    • Recruiting
    • MEDICON a.s. - Poliklinika Bud?jovická
  • České Budějovice, Czechia, 37011
    • Recruiting
    • MUDr. Alena Váchová, Diabetologie
• France
  • Angers, France, 49933
    • Recruiting
    • CHU d'Angers
  • Bois-Guillaume, France, 76230
    • Recruiting
    • CHU de Rouen - HOPITAL Bois Guillaume
  • Paris, France, 75015
    • Recruiting
    • Hopital Européen Georges Pompidou;Service d?endocrinologie, diabétologie et nutrition
  • Paris, France, 75671
    • Recruiting
    • Groupe Hospitalier Pitié Salpétrière;Service d?endocrinologie, diabétologie et nutrition
  • Pessac, France, 33604
    • Recruiting
    • CHU de Bordeaux;Service d?endocrinologie, diabétologie et nutrition
  • Pierre-Bénite, France, 69495
    • Recruiting
    • Centre Hospitalier Lyon Sud
  • Poitiers, France, 86021
    • Recruiting
    • CHU de Poitiers - Hôpital de la Milétrie
  • Saint-Herblain, France, 44800
    • Recruiting
    • CHU de Nantes - Hôpital Laennec
• Germany
  • Essen, Germany, 45355
    • Recruiting
    • Medizentrum Essen Borbeck
  • Essen, Germany, 45136
    • Recruiting
    • InnoDiab Forschung GmbH
  • Essen, Germany, 45359
    • Recruiting
    • Unterfrintroper Hausarztzentrum
  • Hamburg, Germany, 22607
    • Recruiting
    • Diabeteszentrum Hamburg West
  • Hof, Germany, 95030
    • Recruiting
    • Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie
  • Pirna, Germany, 01796
    • Recruiting
    • Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung
• Hungary
  • Balatonfüred, Hungary, 8230
    • Recruiting
    • DRC Gyogyszervizsgalo Kozpont Kft
  • Budapest, Hungary, 1132
    • Recruiting
    • MED-TIMA Kft.
  • Budapest, Hungary, 1122
    • Recruiting
    • Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika
  • Budapest, Hungary, 1213
    • Recruiting
    • Anyagcsere Centrum Csepel/Szatmári-Med Kft.;Diabetology
  • Debrecen, Hungary, 4032
    • Recruiting
    • Debreceni Egyetem, Klinikai Kozpont;Belgyogyaszati Klinika, A epulet
  • Szeged, Hungary, 6725
    • Recruiting
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont;Belgyogyaszati Klinika
  • Székesfehérvár, Hungary, 8000
    • Recruiting
    • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz;2nd Department of Internal Medicine, Nephrological and Diabetological Center
• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Recruiting
      • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Lombardy
    • San Donato Milanese (MI), Lombardy, Italy, 20097
      • Recruiting
      • I.R.C.C.S Policlinico San Donato
  • Sicily
    • Palermo, Sicily, Italy, 90127
      • Recruiting
      • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  • Tuscany
    • Pisa, Tuscany, Italy, 56124
      • Recruiting
      • Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
  • Umbria
    • Perugia, Umbria, Italy, 06129
      • Recruiting
      • Universita degli Studi di Perugia
• 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
• Netherlands
  • Nijmegen, Netherlands, 6525 GA
    • Recruiting
    • Radboud Universitair Medisch Centrum
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • Universitair Medisch Centrum Utrecht
• Poland
  • Bialystok, Poland, 15-435
    • Recruiting
    • NZOZ Specialistyczny Osrodek Internistyczno - Diabetologiczny
  • Bydgoszcz, Poland, 85-231
    • Recruiting
    • Centrum Medyczne Kermed Renata Bijata-Bronisz i Ewa Kowali?ska Sp.j.
  • Gdynia, Poland, 81-157
    • Recruiting
    • Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Cymerman
  • Krakow, Poland, 30-033
    • Recruiting
    • Centrum Medyczne ALL-MED
  • Lublin, Poland, 20-064
    • Recruiting
    • Gabinety Medyczne MATUSZEK
  • Opole, Poland, 45-047
    • Recruiting
    • Centrum Medyczne Clinicly
  • Tarnów, Poland, 33-100
    • Recruiting
    • Osrodek Badan Klinicznych Metabolica
  • Tychy, Poland, 43-100
    • Recruiting
    • Polsko-Amerykanskie Kliniki Serca;X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji
  • Warsaw, Poland, 02-677
    • Recruiting
    • ETG Warszawa
  • Zamo??, Poland, 22-400
    • Recruiting
    • ETG Zamosc
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall d Hebron
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clínico San Carlos
  • Madrid, Spain, 28006
    • Recruiting
    • Hospital Ruber Juan Bravo
  • Seville, Spain, 41950
    • Recruiting
    • Hospital Vithas Sevilla
  • Valencia, Spain, DUMMY_VALUE
    • Recruiting
    • Hospital Universitari i Politècnic La Fe
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marques de Valdecilla
  • LA Coruna
    • A Coruña, LA Coruna, Spain, 15006
      • Recruiting
      • Hospital San Rafael A Coruna
• 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 Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Recruiting
    • Queen Elizabeth University Hospital Glasgow
  • Leicester, United Kingdom, LE5 4PW
    • Recruiting
    • Leicester General Hospital
  • London, United Kingdom, W12 0HS
    • Recruiting
    • Hammersmith Hospital
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Recruiting
    • Royal Victoria Infirmary
  • Swansea, United Kingdom, SA2 8QA
    • Recruiting
    • Singleton Hospital
  • Cambridgeshire
    • Soham, Cambridgeshire, United Kingdom, CB75JD
      • Recruiting
      • Soham Staploe Medical Centre
  • Wiltshire
    • Chippenham, Wiltshire, United Kingdom, SN15 2SB
      • Recruiting
      • Rowden Surgery
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Recruiting
      • Pinnacle Research Group
    • Birmingham, Alabama, United States, 35235
      • Recruiting
      • Alabama Clinical Therapeutics
    • Birmingham, Alabama, United States, 35294-3360
      • Recruiting
      • University of Alabama at Birmingham
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Recruiting
      • Arizona Clinical Trials
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Artemis Institute for Clinical Research, LLC
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale University
  • Georgia
    • Union City, Georgia, United States, 30291
      • Recruiting
      • Rophe Adult and Pediatric Medicine/SKYCRNG
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Recruiting
      • East-West Medical Research Institute
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Recruiting
      • Elevate Clinical Research
    • Schaumburg, Illinois, United States, 60194
      • Recruiting
      • Knownwell
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Recruiting
      • Monroe Biomedical Research
  • Massachusetts
    • Needham, Massachusetts, United States, 02492
      • Recruiting
      • Knownwell
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Recruiting
      • International Diabetes Center At Park Nicollet
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Recruiting
      • DelRicht Research at Gulfport Memorial
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Recruiting
      • Clinvest Research LLC
  • New York
    • Buffalo, New York, United States, 14217
      • Recruiting
      • Rochester Clinical Research
  • Ohio
    • Dayton, Ohio, United States, 45424
      • Recruiting
      • Hometown Urgent Care and Research - Dayton
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Recruiting
      • Delricht Research of Tulsa Clinical Trials
  • Oregon
    • Portland, Oregon, United States, 97210
      • Recruiting
      • Headlands Reseach- Summit
  • Pennsylvania
    • West Chester, Pennsylvania, United States, 19380
      • Recruiting
      • Suburban Research Associates - West Chester Office
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Trial Management Associates
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Recruiting
      • Circle Clinical Research
  • Tennessee
    • Clarksville, Tennessee, United States, 37040
      • Recruiting
      • Innovative Clinical Research
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Clinical Research Associates
  • Texas
    • Bellaire, Texas, United States, 77401
      • Recruiting
      • Bellaire Clinical Research, LLC
    • Brownsville, Texas, United States, 78520
      • Recruiting
      • South Texas Research Institute - Brownsville
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center - Children's Medical Center Dallas
    • Houston, Texas, United States, 77058
      • Recruiting
      • Elevate Clinical
    • McAllen, Texas, United States, 78504
      • Recruiting
      • Elevate Clinical
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • IMA Clinical Research - San Antonio
    • San Antonio, Texas, United States, 78222
      • Recruiting
      • Pinnacle Clinical Research - South San Antonio

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

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 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): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 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