Actively Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Once-Weekly Enicepatide (RO7795068) in Adults With Obesity or Overweight Without Type 2 Diabetes
Led by Hoffmann-La Roche · Updated on 2026-06-01
2000
Participants Needed
73
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of enicepatide, a dual GLP-1/GIP receptor agonist, for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III trial aims to assess the safety and effectiveness of multiple doses of enicepatide compared with placebo, focusing on body weight changes and related health outcomes. The study is sponsored by Hoffmann-La Roche and targets participants with specific body mass index criteria and weight-related health conditions. Participants will be randomly assigned to one of four groups: three different dosing regimens of enicepatide or a placebo. Both enicepatide and placebo are given once weekly using an integrated drug-device combination product. The treatment period lasts 72 weeks, during which the participants receive regular doses as per their assigned group. Throughout the study, participants will be monitored for changes in body weight, waist circumference, blood sugar levels, cholesterol, blood pressure, and quality of life measures. Assessments include physical exams, questionnaires, and imaging such as MRI to measure body composition. Safety is closely tracked through adverse event reporting and mental health assessments. The total participation duration extends through the 72-week treatment and evaluation period, with detailed follow-up on various health indicators.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Body mass index (BMI) of 30.0 kg/m2 or higher; or BMI between 27.0 and less than 30.0 kg/m2 with at least one weight-related health condition such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or weight-related cardiovascular disease
- History of at least one unsuccessful attempt to lose weight through diet or exercise
- Ability and willingness to self-administer the study drug or receive injections from a trained person if needed
You will not qualify if you...
- History of Type 1 or Type 2 diabetes, ketoacidosis, or hyperosmolar state/coma; prior gestational diabetes allowed if no diabetes since
- Weight change greater than 5 kg within 3 months before screening
- Obesity due to other hormonal disorders or genetic/syndromic obesity forms
- Prior or planned obesity surgery; liposuction or abdominoplasty allowed if done more than 1 year before screening
- Known severe gastric emptying problems
- History of acute or chronic pancreatitis or significant gallbladder disease unless treated by surgery over 3 months ago
- Poorly controlled high blood pressure at screening
- Recent major cardiovascular events or hospitalizations within 3 months
- History of unstable or severe psychiatric disorders, except stable mild depression or anxiety without prohibited medications
- Use of any GLP-1 receptor agonist therapies within 6 months before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 72 weeks
Participants receive once-weekly injections of Enicepatide or placebo using an integrated drug-device combination product.
Weekly visits for up to 72 weeks
Trial Site Locations
Total: 73 locations
1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
Actively Recruiting
2
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Actively Recruiting
3
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3360
Actively Recruiting
4
Arizona Clinical Trials
Tucson, Arizona, United States, 85711
Actively Recruiting
5
Artemis Institute for Clinical Research, LLC
San Diego, California, United States, 92123
Actively Recruiting
6
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States, 30291
Actively Recruiting
7
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
Actively Recruiting
8
Elevate Clinical Research
Gurnee, Illinois, United States, 60031
Actively Recruiting
9
Knownwell
Schaumburg, Illinois, United States, 60194
Actively Recruiting
10
Monroe Biomedical Research
Louisville, Kentucky, United States, 40213
Actively Recruiting
11
Knownwell
Needham, Massachusetts, United States, 02492
Actively Recruiting
12
International Diabetes Center At Park Nicollet
Minneapolis, Minnesota, United States, 55416
Actively Recruiting
13
Clinvest Research LLC
Springfield, Missouri, United States, 65807
Actively Recruiting
14
Rochester Clinical Research
Buffalo, New York, United States, 14217
Actively Recruiting
15
Hometown Urgent Care and Research - Dayton
Dayton, Ohio, United States, 45424
Actively Recruiting
16
Headlands Reseach- Summit
Portland, Oregon, United States, 97210
Actively Recruiting
17
Suburban Research Associates - West Chester Office
West Chester, Pennsylvania, United States, 19380
Actively Recruiting
18
Trial Management Associates
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
19
Circle Clinical Research
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
20
Innovative Clinical Research
Clarksville, Tennessee, United States, 37040
Actively Recruiting
21
Clinical Research Associates
Nashville, Tennessee, United States, 37203
Actively Recruiting
22
Bellaire Clinical Research, LLC
Bellaire, Texas, United States, 77401
Actively Recruiting
23
University of Texas Southwestern Medical Center - Children's Medical Center Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
24
Elevate Clinical
Houston, Texas, United States, 77058
Actively Recruiting
25
Elevate Clinical
McAllen, Texas, United States, 78504
Actively Recruiting
26
CINME
Buenos Aires, Argentina, C1056ABI
Actively Recruiting
27
CEDIC Centro de Investigaciones Clinicas
Buenos Aires, Argentina, C1060ABN
Actively Recruiting
28
Centro Medico Viamonte SRL
Buenos Aires, Argentina, C1120AAC
Actively Recruiting
29
IME - Instituto Médico Especializado
Buenos Aires, Argentina, C1405BCH
Actively Recruiting
30
Instituto centenario
Ciudad Autonoma Buenos Aires, Argentina, C1204AAD
Actively Recruiting
31
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, Argentina, C1425AGC
Actively Recruiting
32
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, Argentina, B7600FYK
Actively Recruiting
33
Paratus Clinical Western Sydney
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
34
Baker Heart and Diabetes Insitute
Melbourne, Victoria, Australia, 3004
Actively Recruiting
35
Unity Healthcare Clinic
Surrey, British Columbia, Canada, V3T 4G8
Actively Recruiting
36
Aggarwal and Associates
Brampton, Ontario, Canada, L6T 0G1
Actively Recruiting
37
Hamilton Medical Research Group
Hamilton, Ontario, Canada, L8L 5G4
Actively Recruiting
38
Wharton Medical Clinic
Hamilton, Ontario, Canada, L8L 5G8
Actively Recruiting
39
Bluewater Clinical Research Group
Sarnia, Ontario, Canada, N7T 4X3
Actively Recruiting
40
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, Canada, G9A 4P3
Actively Recruiting
41
MUDr. Alena Váchová, Diabetologie
České Budějovice, Czechia, 37011
Actively Recruiting
42
CHU d'Angers
Angers, France, 49100
Actively Recruiting
43
CHU de Bordeaux;Service d?endocrinologie, diabétologie et nutrition
Pessac, France, 33604
Actively Recruiting
44
CHU de Nantes - Hopital Laennec
Saint-Herblain, France, 44800
Actively Recruiting
45
InnoDiab Forschung GmbH
Essen, Germany, 45136
Actively Recruiting
46
Medizentrum Essen Borbeck
Essen, Germany, 45355
Actively Recruiting
47
Unterfrintroper Hausarztzentrum
Essen, Germany, 45359
Actively Recruiting
48
Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie
Hof, Germany, 95030
Actively Recruiting
49
Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika
Budapest, Hungary, 1122
Actively Recruiting
50
MED-TIMA Kft.
Budapest, Hungary, 1132
Actively Recruiting
51
Anyagcsere Centrum Csepel/Szatmári-Med Kft.;Diabetology
Budapest, Hungary, 1213
Actively Recruiting
52
Debreceni Egyetem, Klinikai Kozpont;Belgyogyaszati Klinika, A epulet
Debrecen, Hungary, 4032
Actively Recruiting
53
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont;Belgyogyaszati Klinika
Szeged, Hungary, 6725
Actively Recruiting
54
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz;2nd Department of Internal Medicine, Nephrological and Diabetological Center
Székesfehérvár, Hungary, 8000
Actively Recruiting
55
Kasugai Municipal Hospital
Aichi, Japan, 486-8510
Actively Recruiting
56
Fukuhama Chuo Clinic
Fukuoka, Japan, 810-0066
Actively Recruiting
57
NTT Medical Center Sapporo
Hokkaido, Japan, 060-0061
Actively Recruiting
58
Hasegawa Medicine Clinic
Hokkaido, Japan, 066-0032
Actively Recruiting
59
Higashijujo Sakai Diabetes Internal Medicine Clinic
Tokyo, Japan, 114-0001
Actively Recruiting
60
NZOZ Specialistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, Poland, 15-435
Actively Recruiting
61
Centrum Medyczne Kermed Renata Bijata-Bronisz i Ewa Kowali?ska Sp.j.
Bydgoszcz, Poland, 85-231
Actively Recruiting
62
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Cymerman
Gdynia, Poland, 81-157
Actively Recruiting
63
ETG Warszawa
Warsaw, Poland, 02-677
Actively Recruiting
64
Hospital San Rafael A Coruna
A Coruña, LA Coruna, Spain, 15006
Actively Recruiting
65
Hospital Vithas Sevilla
Seville, Spain, 41950
Actively Recruiting
66
Changhua Christian Hospital
Changhua, Taiwan, 50006
Actively Recruiting
67
Chia-Yi Christian Hospital
Chiayi City, Taiwan, 600
Actively Recruiting
68
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
69
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Actively Recruiting
70
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
71
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
72
National Taiwan University Hospital
Taipei, Taiwan, 10048
Actively Recruiting
73
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
Research Team
R
Reference Study ID Number: WC45725 https://forpatients.roche.com/ No attachments to email below.
F
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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