RecruitingRecruiting
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
NCT07351045 · 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 Without 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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
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
Study design
Enrollment target: 2000 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-03-16
Estimated completion: 2028-08-28
Last updated: 2026-06-01
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: WC45725 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 (73)
Pinnacle Research GroupRecruiting
Anniston, Alabama, United States
Alabama Clinical TherapeuticsRecruiting
Birmingham, Alabama, United States
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Arizona Clinical TrialsRecruiting
Tucson, Arizona, United States
Artemis Institute for Clinical Research, LLCRecruiting
San Diego, California, United States
Rophe Adult and Pediatric Medicine/SKYCRNGRecruiting
Union City, Georgia, United States
East-West Medical Research InstituteRecruiting
Honolulu, Hawaii, United States
Elevate Clinical ResearchRecruiting
Gurnee, Illinois, United States
KnownwellRecruiting
Schaumburg, Illinois, United States
Monroe Biomedical ResearchRecruiting
Louisville, Kentucky, United States
KnownwellRecruiting
Needham, Massachusetts, United States
International Diabetes Center At Park NicolletRecruiting
Minneapolis, Minnesota, United States
Clinvest Research LLCRecruiting
Springfield, Missouri, United States
Rochester Clinical ResearchRecruiting
Buffalo, New York, United States
Hometown Urgent Care and Research - DaytonRecruiting
Dayton, Ohio, United States
Headlands Reseach- SummitRecruiting
Portland, Oregon, United States
Suburban Research Associates - West Chester OfficeRecruiting
West Chester, Pennsylvania, United States
Trial Management AssociatesRecruiting
Myrtle Beach, South Carolina, United States
Circle Clinical ResearchRecruiting
Sioux Falls, South Dakota, United States
Innovative Clinical ResearchRecruiting
Clarksville, Tennessee, United States
Clinical Research AssociatesRecruiting
Nashville, Tennessee, United States
Bellaire Clinical Research, LLCRecruiting
Bellaire, Texas, United States
University of Texas Southwestern Medical Center - Children's Medical Center DallasRecruiting
Dallas, Texas, United States
Elevate ClinicalRecruiting
Houston, Texas, United States
Elevate ClinicalRecruiting
McAllen, Texas, 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
Baker Heart and Diabetes InsituteRecruiting
Melbourne, Victoria, Australia
Unity Healthcare ClinicRecruiting
Surrey, British Columbia, Canada
Aggarwal and AssociatesRecruiting
Brampton, Ontario, Canada
Hamilton Medical Research GroupRecruiting
Hamilton, Ontario, Canada
Wharton Medical ClinicRecruiting
Hamilton, Ontario, Canada
Bluewater Clinical Research GroupRecruiting
Sarnia, Ontario, Canada
Diex Recherche Trois-RivieresRecruiting
Trois-Rivières, Quebec, Canada
MUDr. Alena Váchová, DiabetologieRecruiting
České Budějovice, Czechia
CHU d'AngersRecruiting
Angers, France
CHU de Bordeaux;Service d?endocrinologie, diabétologie et nutritionRecruiting
Pessac, France
CHU de Nantes - Hopital LaennecRecruiting
Saint-Herblain, France
InnoDiab Forschung GmbHRecruiting
Essen, Germany
Medizentrum Essen BorbeckRecruiting
Essen, Germany
Unterfrintroper HausarztzentrumRecruiting
Essen, Germany
Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & DiabetologieRecruiting
Hof, Germany
Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati KlinikaRecruiting
Budapest, Hungary
MED-TIMA Kft.Recruiting
Budapest, Hungary
Anyagcsere Centrum Csepel/Szatmári-Med Kft.;DiabetologyRecruiting
Budapest, Hungary
Debreceni Egyetem, Klinikai Kozpont;Belgyogyaszati Klinika, A epuletRecruiting
Debrecen, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont;Belgyogyaszati KlinikaRecruiting
Szeged, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz;2nd Department of Internal Medicine, Nephrological and Diabetological CenterRecruiting
Székesfehérvár, Hungary
Kasugai Municipal HospitalRecruiting
Aichi, Japan
Fukuhama Chuo ClinicRecruiting
Fukuoka, Japan
NTT Medical Center SapporoRecruiting
Hokkaido, Japan
Hasegawa Medicine ClinicRecruiting
Hokkaido, Japan
Higashijujo Sakai Diabetes Internal Medicine ClinicRecruiting
Tokyo, Japan
NZOZ Specialistyczny Osrodek Internistyczno - DiabetologicznyRecruiting
Bialystok, Poland
Centrum Medyczne Kermed Renata Bijata-Bronisz i Ewa Kowali?ska Sp.j.Recruiting
Bydgoszcz, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof CymermanRecruiting
Gdynia, Poland
ETG WarszawaRecruiting
Warsaw, Poland
Hospital San Rafael A CorunaRecruiting
A Coruña, LA Coruna, Spain
Hospital Vithas SevillaRecruiting
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