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A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
NCT07351058 · Hoffmann-La Roche
In plain English
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Official title
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
About this study
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).
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
Study design
Enrollment target: 1600 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-03-23
Estimated completion: 2028-08-07
Last updated: 2026-07-20
Interventions
Combination Product: PlaceboCombination Product: Enicepatide
Primary outcomes
- • Percent (%) Change from Baseline in Body Weight at Week 72 (Baseline through Week 72)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: WC45726 https://forpatients.roche.com/ No attachments to email below. · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. Only)
ContactFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry · contact
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (163)
Lakeview Clinical ResearchRecruiting
Guntersville, Alabama, United States
Arizona Clinical TrialsRecruiting
Tucson, Arizona, United States
Orange County Research CenterRecruiting
Lake Forest, California, United States
Ark Clinical ResearchRecruiting
Long Beach, California, United States
Catalina Research Institute, LLCRecruiting
Montclair, California, United States
Infinity Clinical ResearchRecruiting
Norco, California, United States
Prospective Research Innovations Inc.Recruiting
Rancho Cucamonga, California, United States
Encompass Clinical ResearchRecruiting
Spring Valley, California, United States
Emerson Clinical Research InstituteRecruiting
Washington D.C., District of Columbia, United States
Tampa Bay Medical Research, Inc.Recruiting
Clearwater, Florida, United States
Center for Diabetes, Obesity and Metabolism IncRecruiting
Pembroke Pines, Florida, United States
Progressive Medical ResearchRecruiting
Port Orange, Florida, United States
Eirvera, LLCRecruiting
St. Petersburg, Florida, United States
Centricity Research Columbus Georgia MultispecialtyRecruiting
Columbus, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNGRecruiting
Union City, Georgia, United States
Elevate Clinical ResearchRecruiting
Lake Charles, Louisiana, United States
DelRicht Clinical Research, LLCRecruiting
New Orleans, Louisiana, United States
Centennial Medical GroupRecruiting
Columbia, Maryland, United States
Centricity Research Morehead City MultispecialityRecruiting
Morehead City, North Carolina, United States
Remington Davis IncRecruiting
Columbus, Ohio, United States
Lynn Institute of NormanRecruiting
Norman, Oklahoma, United States
Lynn Health Science InstituteRecruiting
Oklahoma City, Oklahoma, United States
Essential Medical ResearchRecruiting
Tulsa, Oklahoma, United States
VA Pittsburgh Healthcare SystemRecruiting
Pittsburgh, Pennsylvania, United States
Coastal Carolina Research CenterRecruiting
North Charleston, South Carolina, United States
Circle Clinical ResearchRecruiting
Sioux Falls, South Dakota, United States
Velocity Clinical ResearchRecruiting
Dallas, Texas, United States
South Texas Research Institute - EdinburgRecruiting
Edinburg, Texas, United States
HRI ? Medical Center, LLCRecruiting
Houston, Texas, United States
Juno Research, LLCRecruiting
Houston, Texas, United States
HRI ? Pasadena, LLCRecruiting
Pasadena, Texas, United States
DM Clinical ResearchRecruiting
Tomball, Texas, United States
Manassas Clinical Research CenterRecruiting
Manassas, Virginia, United States
Centricity Research Suffolk Primary CareRecruiting
Suffolk, Virginia, United States
Era Health ResearchRecruiting
Redmond, Washington, United States
CINMERecruiting
Buenos Aires, Argentina
CEDIC Centro de Investigaciones ClinicasRecruiting
Buenos Aires, Argentina
Centro Medico Viamonte SRLRecruiting
Buenos Aires, Argentina
IME - Instituto Médico EspecializadoRecruiting
Buenos Aires, Argentina
Instituto centenarioRecruiting
Ciudad Autonoma Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica AplicadaRecruiting
Ciudad Autonoma Buenos Aires, Argentina
Centro de Investigaciones Medicas Mar Del PlataRecruiting
Mar del Plata, Argentina
Paratus Clinical Western SydneyRecruiting
Blacktown, New South Wales, Australia
Royal Prince Alfred HospitalRecruiting
Camperdown, New South Wales, Australia
Logan HospitalRecruiting
Meadowbrook, Queensland, Australia
Southern Adelaide Diabetes and Endocrine Services (SADES)Recruiting
Oaklands Park, South Australia, Australia
Baker Heart and Diabetes InsituteRecruiting
Melbourne, Victoria, Australia
Centricity Research Calgary EndocrinologyRecruiting
Calgary, Alberta, Canada
TGElliott Inc. dba BC DiabetesRecruiting
Vancouver, British Columbia, Canada
Centricity Research Brampton EndocrinologyRecruiting
Brampton, Ontario, Canada
Medicor Research IncRecruiting
Greater Sudbury, Ontario, Canada
LMC Clinical Research IncRecruiting
Toronto, Ontario, Canada
Diex Recherche SherbrookeRecruiting
Sherbrooke, Quebec, Canada
Clinique des maladies lipidiques de QuebecRecruiting
Québec, Canada
Huai He Hospital of Henan UniversityRecruiting
Kaifeng, Henan, China
The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu UniversityRecruiting
Zhenjiang, Jiangsu, China
Yan'an University Xianyang HospitalRecruiting
Xianyang, Shaanxi, China
Jinan Central HospitalRecruiting
Jinan, Shandong, China
The First Affiliated Hospital of Ningbo UniversityRecruiting
Ningbo, Zhejiang, China
Peking University People's HospitalRecruiting
Beijing, China
Beijing Pinggu HospitalRecruiting
Beijing, China
The First Hospital of Jilin UniversityRecruiting
Changchun, China
The Second People's Hospital of HefeiRecruiting
Hefei, China
Huizhou Central People's HospitalRecruiting
Huizhou, China
Hebei Petro China Central HospitalRecruiting
Langfang, China
The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
Luoyang, China
The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting
Nanjing, China
Affiliated Drum Tower Hospital of Nanjing University Medical SchoolRecruiting
Nanjing, China
Pingxiang People's HospitalRecruiting
Pingxiang, China
Shanghai Pudong New Area People's HospitalRecruiting
Shanghai, China
Shanghai Fifth People's Hospital Affiliated to Fudan UniversityRecruiting
Shanghai, China
The First Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, China
Wuxi People's HospitalRecruiting
Wuxi, China
DIACENTRUM Brandýs nad Labem s.r.o.Recruiting
Brandýs nad Labem, Czechia
Diavital Jesenice s.r.o.Recruiting
Jesenice, Czechia
FLEDIP s.r.o.Recruiting
Prague, Czechia
TreDia s.r.o.;Diabetologická ambulance Praha 9Recruiting
Praha 9 - Klánovice, Czechia
Hopital Saint Joseph Saint LucRecruiting
Lyon, France
Hopital de la ConceptionRecruiting
Marseille, France
CHU de NiceRecruiting
Nice, France
European Hospital Georges Pompidou (HEGP)Recruiting
Paris, France
Chu De ToursRecruiting
Tours, France
Hector-Center für Ernährung, Bewegung und Sport, Universitätsklinikum Erlangen;Medizinische Klinik 1 ? Gastroenterologie, Pneumologie und EndokrinologieRecruiting
Erlangen, Germany
InnoDiab Forschung GmbHRecruiting
Essen, Germany
Medizentrum Essen BorbeckRecruiting
Essen, Germany
Unterfrintroper HausarztzentrumRecruiting
Essen, Germany
Universitaets Klinikum Frankfurt - Zentrum der Inneren MedizinNot Yet Recruiting
Frankfurt, Germany
Diabeteszentrum Hamburg WestRecruiting
Hamburg, Germany
Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & DiabetologieRecruiting
Hof, Germany
Zentrum für klinische Forschung Köln - Dünnwald;Dünnwald PraxisRecruiting
Köln - Dünnwald, Germany
Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Dr. med. Winfried KeuthageRecruiting
Münster, Germany
Diabetologische Schwerpunktpraxis Pirna Hausärztliche VersorgungRecruiting
Pirna, Germany
Azienda Ospedaliera Papa Giovanni XXIIIRecruiting
Bergamo, Abruzzo, Italy
Azienda Ospedaliero-Universitaria "Renato Dulbecco" CatanzaroRecruiting
Catanzaro, Calabria, Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di BolognaRecruiting
Bologna, Emilia-Romagna, Italy
Umberto I Policlinico di Roma-Università di Roma La SapienzaRecruiting
Rome, Lazio, Italy
Policlinico Universitario Agostino GemelliRecruiting
Rome, Lazio, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo GiacconeRecruiting
Palermo, Sicily, Italy
AO di Perugia - Ospedale S. Maria della MisericordiaRecruiting
Perugia, Umbria, Italy
Kasugai Municipal HospitalRecruiting
Aichi, Japan
Fukuhama Chuo ClinicRecruiting
Fukuoka, Japan
NTT Medical Center SapporoRecruiting
Hokkaido, Japan
Hasegawa Medicine ClinicRecruiting
Hokkaido, Japan
The University of Osaka HospitalRecruiting
Osaka, Japan
Higashijujo Sakai Diabetes Internal Medicine ClinicRecruiting
Tokyo, Japan
Arechavaleta Granell Maria del RosarioRecruiting
Guadalajara, Jalisco, Mexico
Clinicos Asociados Bocm, S.C.Recruiting
México, Mexico CITY (federal District), Mexico
Avant Santé Research CenterRecruiting
San Pedro Garza García, Nuevo León, Mexico
NZOZ Osteo-Medic s.c. A. Racewicz, J.SupronikRecruiting
Bialystok, Podlaskie Voivodeship, Poland
Centrum Medyczne INTERCOR Sp. z o.o.Recruiting
Bydgoszcz, Poland
ETG DebicaRecruiting
Dębica, Poland
Ekamed sp. z o.o.Recruiting
Lublin, Poland
NZOZ Eskulap PabianiceRecruiting
Pabianice, Poland
Centrum Medyczne OMEDICARecruiting
Poznan, Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki s.c.Recruiting
Ruda Śląska, Poland
ETG SiedlceRecruiting
Siedlce, Poland
Panstwowy Instytut Medyczny - MSWiARecruiting
Warsaw, Poland
NZOZ Regionalna Poradnia DiabetologicznaRecruiting
Wroclaw, Poland
FDI Clinical ResearchRecruiting
San Juan, Puerto Rico
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggido, South Korea
Yonsei University Wonju Severance Christian HospitalRecruiting
Gangwon-do, South Korea
Chosun University HospitalRecruiting
Gwangju, South Korea
Eulji General HospitalRecruiting
Seoul, South Korea
Kangbuk Samsung HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Hospital Universitari Germans Trias i PujolRecruiting
Badalona, Barcelona, Spain
Complejo Hospitalario Universitario A CoruñaRecruiting
A Coruña, LA Coruna, Spain
Hospital Universitario Quironsalud MadridRecruiting
Pozuelo de Alarcón, Madrid, Spain
Centro Medico TeknonRecruiting
Barcelona, Spain
Hospital Universitari Vall d HebronRecruiting
Barcelona, Spain
Hospital Gregorio MarañonRecruiting
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz.Recruiting
Madrid, Spain
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Spain
Nuevas Tecnologias en Diabetes y EndocrinologiaRecruiting
Seville, Spain
Changhua Christian HospitalRecruiting
Changhua, Taiwan
Chia-Yi Christian HospitalRecruiting
Chiayi City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Chung Shan Medical University HospitalRecruiting
Taichung, Taiwan
China Medical University HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Rajavithi HospitalRecruiting
Bangkok, Thailand
Ramathibodi HospitalRecruiting
Bangkok, Thailand
Siriraj HospitalRecruiting
Bangkok, Thailand
Division of Endocrinology and Metabolism;Internal MedicineRecruiting
Chiang Mai, Thailand
Songklanagarind HospitalRecruiting
Hat Yai, Thailand
Thammasat University HospitalRecruiting
Khlong Luang, Thailand
Ankara University Medical FacultyRecruiting
Ankara, Turkey (Türkiye)
Akdeniz University Medical FacultyRecruiting
Antalya, Turkey (Türkiye)
Dokuz Eylul University Medicine FacultyRecruiting
Izmir, Turkey (Türkiye)
Baskent Universitesi - Adana Uygulama Ve Arastirma MerkeziRecruiting
Sariçam, Turkey (Türkiye)
Fylde Coast Clinical Research at Layton Medical CentreRecruiting
Blackpool, Lancashire, United Kingdom
Aberdeen Royal InfirmaryRecruiting
Aberdeen, United Kingdom
Antrim Area HospitalRecruiting
Antrim, United Kingdom
Southmead General HospitalRecruiting
Bristol, United Kingdom
Ninewells Hospital and Medical School - Tayside Health BoardRecruiting
Dundee, United Kingdom
Hull Royal InfirmaryRecruiting
Hull, United Kingdom
HMC Health GroupRecruiting
London, United Kingdom
George Eliot HospitalRecruiting
Nuneaton, United Kingdom
Knowle House SurgeryRecruiting
Plymouth, United Kingdom
Musgrove Park HospitalRecruiting
Taunton, United Kingdom