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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 and Type 2 Diabetes

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT07351058

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

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: * 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

Conditions

Obesity or Overweight Type 2 Diabetes Mellitus

Locations

  • Lakeview Clinical Research — Guntersville, Alabama, United States
  • Arizona Clinical Trials — Tucson, Arizona, United States
  • University of California Irvine — Irvine, California, United States
  • Orange County Research Center — Lake Forest, California, United States
  • Ark Clinical Research — Long Beach, California, United States
  • Catalina Research Institute, LLC — Montclair, California, United States
  • Infinity Clinical Research — Norco, California, United States
  • Prospective Research Innovations Inc. — Rancho Cucamonga, California, United States
  • Encompass Clinical Research — Spring Valley, California, United States
  • Emerson Clinical Research Institute — Washington D.C., District of Columbia, United States
  • Tampa Bay Medical Research, Inc. — Clearwater, Florida, United States
  • Center for Diabetes, Obesity and Metabolism Inc — Pembroke Pines, Florida, United States
  • Progressive Medical Research — Port Orange, Florida, United States
  • Eirvera, LLC — St. Petersburg, Florida, United States
  • Centricity Research Columbus Georgia Multispecialty — Columbus, Georgia, United States
  • Atlanta Veterans Affairs Medical Center — Decatur, Georgia, United States
  • Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States
  • Elite Clinical Trials — Blackfoot, Idaho, United States
  • Central Illinois Diabetes and Clinical Research — Springfield, Illinois, United States
  • Elevate Clinical Research — Lake Charles, Louisiana, United States
  • Nola Care Clinical Research Center — Metairie, Louisiana, United States
  • DelRicht Clinical Research, LLC — New Orleans, Louisiana, United States
  • Centennial Medical Group — Columbia, Maryland, United States
  • Olive Branch Family Medical Center — Olive Branch, Mississippi, United States
  • Kansas City VA Medical Center — Kansas City, Missouri, United States
  • Centricity Research Morehead City Multispeciality — Morehead City, North Carolina, United States
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
  • Remington Davis Inc — Columbus, Ohio, United States
  • Lynn Institute of Norman — Norman, Oklahoma, United States
  • Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
  • Essential Medical Research — Tulsa, Oklahoma, United States
  • VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States
  • Coastal Carolina Research Center — North Charleston, South Carolina, United States
  • Circle Clinical Research — Sioux Falls, South Dakota, United States
  • Headlands Research Brownsville — Brownsville, Texas, United States
  • Velocity Clinical Research — Dallas, Texas, United States
  • South Texas Research Institute - Edinburg — Edinburg, Texas, United States
  • HRI ? Medical Center, LLC — Houston, Texas, United States
  • Juno Research, LLC — Houston, Texas, United States
  • HRI ? Pasadena, LLC — Pasadena, Texas, United States
  • Pinnacle Clinical Research - San Antonio — San Antonio, Texas, United States
  • DM Clinical Research — Tomball, Texas, United States
  • Manassas Clinical Research Center — Manassas, Virginia, United States
  • Centricity Research Suffolk Primary Care — Suffolk, Virginia, United States
  • Era Health Research — Redmond, Washington, 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 Prince Alfred Hospital — Camperdown, New South Wales, Australia
  • Logan Hospital — Meadowbrook, Queensland, 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
  • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás — Goiânia, Goiás, Brazil
  • Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR — Porto Alegre, Rio Grande do Sul, Brazil
  • Clinica do Coracao — Aracaju, Sergipe, 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
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo — São Paulo, São Paulo, Brazil
  • IBPCLIN Instituto Brasil de Pesquisa Clinica — Rio de Janeiro, Brazil
  • Centricity Research Calgary Endocrinology — Calgary, Alberta, Canada
  • TGElliott Inc. dba BC Diabetes — Vancouver, British Columbia, Canada
  • Centricity Research Brampton Endocrinology — Brampton, Ontario, Canada
  • Medicor Research Inc — Greater Sudbury, Ontario, Canada
  • LMC Clinical Research Inc — Toronto, Ontario, Canada
  • Applied Medical Informatics Research Inc. (A.M.I.R.) — Montreal, Quebec, Canada
  • Diex Recherche Sherbrooke East — Sherbrooke, Quebec, Canada
  • Clinique des maladies lipidiques de Quebec — Québec, Canada
  • Cangzhou People's Hospital — Cangzhou, Hebei, China
  • Huai He Hospital of Henan University — Kaifeng, Henan, China
  • The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China
  • Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China
  • Yan'an University Xianyang Hospital — Xianyang, Shaanxi, China
  • Jinan Central Hospital — Jinan, Shandong, China
  • The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, 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
  • Affiliated Drum Tower Hospital of Nanjing University Medical School — Nanjing, China
  • Pingxiang People's Hospital — Pingxiang, China
  • Shanghai Pudong New Area People's Hospital — Shanghai, China
  • Shanghai Fifth People's Hospital Affiliated to Fudan University — Shanghai, China
  • Siping Central People's Hospital — Siping, China
  • The First Affiliated Hospital of Soochow University — Suzhou, China
  • Wuxi People's Hospital — Wuxi, China
  • The First Affiliated Hospital of Xi'an Medical University — Xi'an, China
  • Yueyang Central Hospital — Yueyang, China
  • DIACENTRUM Brandýs nad Labem s.r.o. — Brandýs nad Labem, Czechia
  • Diavital Jesenice s.r.o. — Jesenice, Czechia
  • Institut klinické a experimentální medicíny (IKEM);centrum diabetologie — Prague, Czechia
  • FLEDIP s.r.o. — Prague, Czechia
  • Úst?ední vojenská nemocnice;Diabetologické centrum — Prague, Czechia
  • TreDia s.r.o.;Diabetologická ambulance Praha 9 — Praha 9 - Klánovice, Czechia
  • Hopital Saint Joseph Saint Luc — Lyon, France
  • Hopital de la Conception — Marseille, France
  • CHU de Nice — Nice, France
  • European Hospital Georges Pompidou (HEGP) — Paris, France
  • Chu De Tours — Tours, 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
  • MVZ Diabeteszentrum Dr. Tews GmbH;Praxis für Diabetologie — Gelnhausen, 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
  • Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Dr. med. Winfried Keuthage — Münster, Germany
  • Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung — Pirna, Germany
  • Azienda Ospedaliera Papa Giovanni XXIII — Bergamo, Abruzzo, Italy
  • Azienda Ospedaliero-Universitaria "Renato Dulbecco" Catanzaro — Catanzaro, Calabria, Italy
  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna — Bologna, Emilia-Romagna, Italy
  • Umberto I Policlinico di Roma-Università di Roma La Sapienza — Rome, Lazio, Italy
  • Policlinico Universitario Agostino Gemelli — Rome, Lazio, Italy
  • Asst Grande Ospedale Metropolitano Niguarda — Milan, Lombardy, Italy
  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone — Palermo, Sicily, Italy
  • AO di Perugia - Ospedale S. Maria della Misericordia — 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
  • 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
  • CEMDEC S.A. de C.V. — Delegacion Cuauhtemoc, Mexico, Mexico
  • Instituto de Diabetes Obesidad y Nutricion, SC — 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
  • NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik — Bialystok, Podlaskie Voivodeship, Poland
  • Centrum Medyczne INTERCOR Sp. z o.o. — Bydgoszcz, Poland
  • ETG Debica — Dębica, Poland
  • Ekamed sp. z o.o. — Lublin, Poland
  • NZOZ Eskulap Pabianice — Pabianice, Poland
  • Centrum Medyczne OMEDICA — Poznan, Poland
  • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki s.c. — Ruda Śląska, Poland
  • ETG Siedlce — Siedlce, Poland
  • Panstwowy Instytut Medyczny - MSWiA — Warsaw, Poland
  • NZOZ Regionalna Poradnia Diabetologiczna — Wroclaw, Poland
  • FDI Clinical Research — San Juan, Puerto Rico
  • Spitalul Clinic Judetean de Urgenta 'Pius Brinzeu' Timisoara — Timișoara, Romania
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggido, South Korea
  • Eulji University Hospital — Daejeon, South Korea
  • Yonsei University Wonju Severance Christian Hospital — Gangwon-do, South Korea
  • Chosun University Hospital — Gwangju, South Korea
  • Uijeongbu St. Mary's Hospital — Gyeonggi-do, South Korea
  • Eulji General Hospital — Seoul, South Korea
  • Kangbuk Samsung Hospital — Seoul, South Korea
  • Severance Hospital, Yonsei University Health System — Seoul, South Korea
  • Gangdong Kyung Hee University Hospital — Seoul, South Korea
  • Hallym University Kangnam Sacred Heart Hospital — Seoul, South Korea
  • Hospital Universitari Germans Trias i Pujol — Badalona, Barcelona, Spain
  • Complejo Hospitalario Universitario A Coruña — A Coruña, LA Coruna, Spain
  • Complejo Hospitalario Universitario de Ferrol — Ferrol, LA Coruna, Spain
  • Hospital Universitario Quironsalud Madrid — Pozuelo de Alarcón, Madrid, Spain
  • Centro Medico Teknon — Barcelona, Spain
  • Hospital Universitari Vall d Hebron — Barcelona, Spain
  • Hospital Gregorio Marañon — Madrid, Spain
  • Hospital Universitario Fundacion Jimenez Diaz. — Madrid, Spain
  • Hospital Universitario Virgen de la Victoria — Málaga, Spain
  • Nuevas Tecnologias en Diabetes y Endocrinologia — Seville, 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
  • Rajavithi Hospital — Bangkok, Thailand
  • Ramathibodi Hospital — Bangkok, Thailand
  • Siriraj Hospital — Bangkok, Thailand
  • Division of Endocrinology and Metabolism;Internal Medicine — Chiang Mai, Thailand
  • Songklanagarind Hospital — Hat Yai, Thailand
  • Thammasat University Hospital — Khlong Luang, Thailand
  • Koc University Medical Faculty Hospital — Istanbul, Zeytinburnu, Turkey (Türkiye)
  • Adana Sehir Egitim ve Arastirma Hastanesi — Adana, Turkey (Türkiye)
  • Ankara University Medical Faculty — Ankara, Turkey (Türkiye)
  • Akdeniz University Medical Faculty — Antalya, Turkey (Türkiye)
  • Kanuni Sultan Suleyman Training and Research Hospital — Istanbul, Turkey (Türkiye)
  • Medeniyet University Goztepe Training and Research Hospital — Istanbul, Turkey (Türkiye)
  • Dokuz Eylul University Medicine Faculty — Izmir, Turkey (Türkiye)
  • Baskent Universitesi - Adana Uygulama Ve Arastirma Merkezi — Sariçam, Turkey (Türkiye)
  • Fylde Coast Clinical Research at Layton Medical Centre — Blackpool, Lancashire, United Kingdom
  • Aberdeen Royal Infirmary — Aberdeen, United Kingdom
  • Antrim Area Hospital — Antrim, United Kingdom
  • Southmead General Hospital — Bristol, United Kingdom
  • Ninewells Hospital and Medical School - Tayside Health Board — Dundee, United Kingdom
  • HMC Health Group — Hounslow, United Kingdom
  • Hull Royal Infirmary — Hull, United Kingdom
  • George Eliot Hospital — Nuneaton, United Kingdom
  • Knowle House Surgery — Plymouth, United Kingdom
  • Musgrove Park Hospital — Taunton, 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