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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT07351045

Registry updated: 2026-10-13
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Description

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.

Interventions

  • Placebo (Combination product)
    Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
  • Enicepatide (Combination product)
    Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

Eligibility criteria

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

Conditions

Obesity or Overweight

Locations

  • Pinnacle Research Group — Anniston, Alabama, United States
  • Alabama Clinical Therapeutics — Birmingham, Alabama, United States
  • University of Alabama at Birmingham — Birmingham, Alabama, United States
  • Arizona Clinical Trials — Tucson, Arizona, United States
  • University of California Irvine — Irvine, California, United States
  • Artemis Institute for Clinical Research, LLC — San Diego, California, United States
  • Diablo Clinical Research, Inc. — Walnut Creek, California, United States
  • Yale University — New Haven, Connecticut, United States
  • Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States
  • East-West Medical Research Institute — Honolulu, Hawaii, United States
  • Elevate Clinical Research — Gurnee, Illinois, United States
  • Knownwell — Schaumburg, Illinois, United States
  • Endeavor Health — Skokie, Illinois, United States
  • Monroe Biomedical Research — Louisville, Kentucky, United States
  • Ascension DePaul Health — New Orleans, Louisiana, United States
  • Baltimore VA Medical Center — Baltimore, Maryland, United States
  • Johns Hopkins University School of Nursing — Baltimore, Maryland, United States
  • Boston Medical Center — Boston, Massachusetts, United States
  • Knownwell — Needham, Massachusetts, United States
  • International Diabetes Center At Park Nicollet — Minneapolis, Minnesota, United States
  • DelRicht Research at Gulfport Memorial — Gulfport, Mississippi, United States
  • Clinvest Research LLC — Springfield, Missouri, United States
  • Rochester Clinical Research — Buffalo, New York, United States
  • Hometown Urgent Care and Research - Dayton — Dayton, Ohio, United States
  • Delricht Research of Tulsa Clinical Trials — Tulsa, Oklahoma, United States
  • Headlands Reseach- Summit — Portland, Oregon, United States
  • Suburban Research Associates - West Chester Office — West Chester, Pennsylvania, United States
  • Trial Management Associates — Myrtle Beach, South Carolina, United States
  • Circle Clinical Research — Sioux Falls, South Dakota, United States
  • Innovative Clinical Research — Clarksville, Tennessee, United States
  • Clinical Research Associates — Nashville, Tennessee, United States
  • Bellaire Clinical Research, LLC — Bellaire, Texas, United States
  • South Texas Research Institute - Brownsville — Brownsville, Texas, United States
  • South Texas Clinical Research — Corpus Christi, Texas, United States
  • University of Texas Southwestern Medical Center - Children's Medical Center Dallas — Dallas, Texas, United States
  • Elevate Clinical — Houston, Texas, United States
  • Houston Research Institute — Houston, Texas, United States
  • Elevate Clinical — McAllen, Texas, United States
  • Pinnacle Clinical Research - South San Antonio — San Antonio, Texas, United States
  • IMA Clinical Research - San Antonio — San Antonio, Texas, United States
  • Consano Clinical Research — Shavano Park, Texas, United States
  • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance — Southlake, Texas, United States
  • George E. Wahlen Department of Veterans Affairs Medical Center — Salt Lake City, Utah, United States
  • Ascension Columbia St. Mary's — Milwaukee, Wisconsin, United States
  • CINME — Buenos Aires, Argentina
  • CEDIC Centro de Investigaciones Clinicas — Buenos Aires, Argentina
  • Centro Medico Viamonte SRL — Buenos Aires, Argentina
  • IME - Instituto Médico Especializado — Buenos Aires, Argentina
  • Instituto centenario — Ciudad Autonoma Buenos Aires, Argentina
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Ciudad Autonoma Buenos Aires, Argentina
  • Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata, Argentina
  • Paratus Clinical Western Sydney — Blacktown, New South Wales, Australia
  • Royal North Shore Hospital — St Leonards, New South Wales, Australia
  • Southern Adelaide Diabetes and Endocrine Services (SADES) — Oaklands Park, South Australia, Australia
  • Heidelberg Repatriation Hospital — Heidelberg, Victoria, Australia
  • Baker Heart and Diabetes Insitute — Melbourne, Victoria, Australia
  • AZORG Campus Aalst-Moorselbaan — Aalst, Belgium
  • Hospital Erasme — Brussels, Belgium
  • UZ Leuven Gasthuisberg — Leuven, Belgium
  • CHU de Liège (Sart Tilman) — Liège, Belgium
  • AZ Delta (Campus Rumbeke) — Roeselare, Belgium
  • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás — Goiânia, Goiás, Brazil
  • Hospital Universitário Onofre Lopes - UFRN — Natal, Rio Grande do Norte, Brazil
  • Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR — Porto Alegre, Rio Grande do Sul, Brazil
  • Hospital de Base de Sao Jose do Rio Preto — São José do Rio Preto, São Paulo, Brazil
  • CPQuali Pesquisa Clinica Ltda — São Paulo, São Paulo, Brazil
  • Centro de Pesquisas Clinicas — São Paulo, São Paulo, Brazil
  • BR Trials - Pesquisa Clínica — São Paulo, São Paulo, Brazil
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo — São Paulo, São Paulo, Brazil
  • C-health Partners Inc — Calgary, Alberta, Canada
  • Unity Healthcare Clinic — Surrey, British Columbia, Canada
  • Aggarwal and Associates — Brampton, Ontario, Canada
  • Hamilton Medical Research Group — Hamilton, Ontario, Canada
  • Wharton Medical Clinic — Hamilton, Ontario, Canada
  • Bluewater Clinical Research Group — Sarnia, Ontario, Canada
  • Diex Recherche Trois-Rivieres — Trois-Rivières, Quebec, Canada
  • Alpha Recherche Clinique — Québec, Canada
  • Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China
  • Yan'an University Xianyang Hospital — Xianyang, Shaanxi, China
  • Jinan Central Hospital — Jinan, Shandong, China
  • Peking University People's Hospital — Beijing, China
  • Beijing Pinggu Hospital — Beijing, China
  • The First Hospital of Jilin University — Changchun, China
  • The Second People's Hospital of Hefei — Hefei, China
  • The Fourth Affiliated Hospital of Harbin Medical University — Herbin, China
  • Huizhou Central People's Hospital — Huizhou, China
  • Hebei Petro China Central Hospital — Langfang, China
  • The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, China
  • The Second Affiliated Hospital of Nanjing Medical University — Nanjing, China
  • Pingxiang People's Hospital — Pingxiang, China
  • Shanghai Pudong New Area People's Hospital — Shanghai, China
  • The First Affiliated Hospital of Soochow University — Suzhou, China
  • MUDr. Alena Váchová, Diabetologie — České Budějovice, Czechia
  • Edumed s.r.o.;Diabetologická ambulance — Náchod, Czechia
  • DIALINE s.r.o. — Plze?, Czechia
  • MediSpo Clinic — Prague, Czechia
  • DiaVize — Prague, Czechia
  • MEDICON a.s. - Poliklinika Bud?jovická — Prague, Czechia
  • CHU d'Angers — Angers, France
  • CHU de Rouen - HOPITAL Bois Guillaume — Bois-Guillaume, France
  • CHU Dijon - Hopital Francois Mitterrand — Dijon, France
  • Hopital Européen Georges Pompidou;Service d?endocrinologie, diabétologie et nutrition — Paris, France
  • Groupe Hospitalier Pitié Salpétrière;Service d?endocrinologie, diabétologie et nutrition — Paris, France
  • CHU de Bordeaux;Service d?endocrinologie, diabétologie et nutrition — Pessac, France
  • Centre Hospitalier Lyon Sud — Pierre-Bénite, France
  • CHU DE POITIERS - Hôpital de la Milétrie — Poitiers, France
  • CHU de Nantes - Hopital Laennec — Saint-Herblain, France
  • Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum Medizinische Fakultät OWL (Universität Bielefeld);Klinik für Diabetologie und Endokrinologie — Bad Oeynhausen, Germany
  • Hector-Center für Ernährung, Bewegung und Sport, Universitätsklinikum Erlangen;Medizinische Klinik 1 ? Gastroenterologie, Pneumologie und Endokrinologie — Erlangen, Germany
  • InnoDiab Forschung GmbH — Essen, Germany
  • Medizentrum Essen Borbeck — Essen, Germany
  • Unterfrintroper Hausarztzentrum — Essen, Germany
  • Universitaets Klinikum Frankfurt - Zentrum der Inneren Medizin — Frankfurt, Germany
  • Diabeteszentrum Hamburg West — Hamburg, Germany
  • Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie — Hof, Germany
  • Zentrum für klinische Forschung Köln - Dünnwald;Dünnwald Praxis — Köln - Dünnwald, Germany
  • Medicover Neuroendokrinologie MVZ - Prof. Stalla und Kollegen;Praxis für Neuroendokrinologie — München, Germany
  • Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Dr. med. Winfried Keuthage — Münster, Germany
  • Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung — Pirna, Germany
  • DRC Gyogyszervizsgalo Kozpont Kft — Balatonfüred, Hungary
  • Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika — Budapest, Hungary
  • MED-TIMA Kft. — Budapest, Hungary
  • Anyagcsere Centrum Csepel/Szatmári-Med Kft.;Diabetology — Budapest, Hungary
  • Debreceni Egyetem, Klinikai Kozpont;Belgyogyaszati Klinika, A epulet — Debrecen, Hungary
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont;Belgyogyaszati Klinika — Szeged, Hungary
  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz;2nd Department of Internal Medicine, Nephrological and Diabetological Center — Székesfehérvár, Hungary
  • Marengo CIMS Hospital — Ahmedabad, Gujarat, India
  • Jothydev's Diabetes Research Centre — Trivandrum, Kerala, India
  • Wockhardt Hospitals — Mumbai, Maharashtra, India
  • Grant Medical Foundation, Ruby Hall Clinic — Pune, Maharashtra, India
  • Deenanath Mangeshkar Hospital & Research Centre — Pune, Maharashtra, India
  • Chellaram Diabetes Institute;Diabetes and Endocrinology — Pune, Maharashtra, India
  • Azienda Ospedaliera Papa Giovanni XXIII — Bergamo, Abruzzo, Italy
  • Policlinico di Bari — Bari, Apulia, Italy
  • Azienda Ospedaliero-Universitaria "Renato Dulbecco" Catanzaro — Catanzaro, Calabria, Italy
  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna — Bologna, Emilia-Romagna, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Lazio, Italy
  • I.R.C.C.S Policlinico San Donato — San Donato Milanese (MI), Lombardy, Italy
  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone — Palermo, Sicily, Italy
  • Università Degli Studi di Pisa - Ospedale di Cisanello Pisa — Pisa, Tuscany, Italy
  • Universita Degli Studi Di Perugia — Perugia, Umbria, Italy
  • Kasugai Municipal Hospital — Aichi, Japan
  • Fukuhama Chuo Clinic — Fukuoka, Japan
  • NTT Medical Center Sapporo — Hokkaido, Japan
  • Hasegawa Medicine Clinic — Hokkaido, Japan
  • The University of Osaka Hospital — Osaka, Japan
  • The University of Tokyo Hospital — Tokyo, Japan
  • Higashijujo Sakai Diabetes Internal Medicine Clinic — Tokyo, Japan
  • Medical Center Metas SC — Col Saucito, Chihuahua, Mexico
  • Arechavaleta Granell Maria del Rosario — Guadalajara, Jalisco, Mexico
  • Instituto Jalisciense de investigacion en diabetes y obesidad S.C. — Guadalajara, Jalisco, Mexico
  • CEMDEC S.A. de C.V. — Delegacion Cuauhtemoc, Mexico CITY (federal District), Mexico
  • Clinicos Asociados Bocm, S.C. — México, Mexico CITY (federal District), Mexico
  • Instittuto Nacional de Ciencias Medicas y Nutricion "Salvador Subiran" — México, Mexico CITY (federal District), Mexico
  • Instituto de Diabetes, Obesidad y Nutricion S.C. Coordinacion — Cuernavaca, Morelos, Mexico
  • Avant Santé Research Center — San Pedro Garza García, Nuevo León, Mexico
  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares SC — Ciudad Madero, Tamaulipas, Mexico
  • Amsterdam UMC Location AMC — Amsterdam, Netherlands
  • Radboud Universitair Medisch Centrum — Nijmegen, Netherlands
  • Erasmus MC — Rotterdam, Netherlands
  • Universitair Medisch Centrum Utrecht — Utrecht, Netherlands
  • Isala — Zwolle, Netherlands
  • NZOZ Specialistyczny Osrodek Internistyczno - Diabetologiczny — Bialystok, Poland
  • Centrum Medyczne Kermed Renata Bijata-Bronisz i Ewa Kowali?ska Sp.j. — Bydgoszcz, Poland
  • Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Cymerman — Gdynia, Poland
  • Centrum Medyczne ALL-MED — Krakow, Poland
  • Gabinety Medyczne MATUSZEK — Lublin, Poland
  • Centrum Medyczne Clinicly — Opole, Poland
  • Osrodek Badan Klinicznych Metabolica — Tarnów, Poland
  • Polsko-Amerykanskie Kliniki Serca;X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji — Tychy, Poland
  • ETG Warszawa — Warsaw, Poland
  • ETG Zamosc — Zamo??, Poland
  • Kyungpook National University Hospital — Daegu, Daegu Gwang'yeogsi, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggido, South Korea
  • Konyang University Hospital — Daejeon, South Korea
  • Chosun University Hospital — Gwangju, South Korea
  • Hanyang University Guri Hospital — Gyeonggi-do, South Korea
  • Bucheon St Mary's hospital — Gyeonggi-do, South Korea
  • Gachon University Gil Medical Center — Incheon, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Kangbuk Samsung Hospital — Seoul, South Korea
  • Asan Medical Center — Seoul, South Korea
  • Hospital Universitario Marques de Valdecilla — Santander, Cantabria, Spain
  • Hospital San Rafael A Coruna — A Coruña, LA Coruna, Spain
  • Clinica Universidad de Navarra — Pamplona, Navarre, Spain
  • Hospital del Mar — Barcelona, Spain
  • Hospital Universitario Vall d Hebron — Barcelona, Spain
  • Hospital Ruber Juan Bravo — Madrid, Spain
  • Hospital Clinico San Carlos — Madrid, Spain
  • Hospital Quironsalud Infanta Luisa — Seville, Spain
  • Hospital Vithas Sevilla — Seville, Spain
  • Hospital Universitari i Politècnic La Fe — Valencia, Spain
  • Changhua Christian Hospital — Changhua, Taiwan
  • Chia-Yi Christian Hospital — Chiayi City, Taiwan
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
  • Chung Shan Medical University Hospital — Taichung, Taiwan
  • China Medical University Hospital — Taichung, Taiwan
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
  • Soham Staploe Medical Centre — Soham, Cambridgeshire, United Kingdom
  • Rowden Surgery — Chippenham, Wiltshire, United Kingdom
  • Monklands Hospital — Airdrie, United Kingdom
  • Birmingham Heartlands Hospital — Birmingham, United Kingdom
  • Queen Elizabeth University Hospital Glasgow — Glasgow, United Kingdom
  • Leicester General Hospital — Leicester, United Kingdom
  • Hammersmith Hospital — London, United Kingdom
  • Royal Victoria Infirmary — Newcastle upon Tyne, United Kingdom
  • Singleton Hospital — Swansea, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record