Actively Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Once-Weekly Enicepatide (RO7795068) for Weight Management in Participants With Obesity or Overweight and Type 2 Diabetes
Led by Hoffmann-La Roche · Updated on 2026-05-26
1600
Participants Needed
61
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating enicepatide, a drug that acts on two receptors related to blood sugar and weight control, for its effects on weight management in people with obesity or overweight who also have Type 2 diabetes mellitus (T2DM). This Phase III study compares multiple doses of enicepatide to a placebo to assess both effectiveness and safety over a long period. 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 study uses a double-blind design, so neither participants nor researchers know who receives the active drug or placebo. Treatment lasts for 72 weeks, allowing detailed assessment of changes over time. Throughout the study, participants will regularly have their body weight measured to track percentage change from baseline, along with many other health indicators including blood sugar levels, cholesterol, blood pressure, and quality of life surveys. Safety will also be closely monitored through assessments of adverse events and specific health questionnaires. The total participation period extends through 72 weeks of treatment and follow-up to observe long-term effects.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to self-administer the study drug or receive injections from a trained individual if needed
- Diagnosed with type 2 diabetes mellitus with HbA1c between 6.5% and 10% at screening
- On stable oral diabetes therapy for at least 3 months before screening, excluding DPP-4 inhibitors and GLP-1 receptor agonists
- Body mass index (BMI) of 27.0 kg/m² or higher
- History of at least one unsuccessful attempt to lose weight with diet or exercise
You will not qualify if you...
- History of type 1 diabetes mellitus or ketoacidosis or hyperosmolar state/coma within 12 months before screening
- Experienced severe hypoglycemia or hypoglycemia unawareness in the past 6 months
- Two or more fasting blood glucose readings above 270 mg/dL during screening
- Body weight change greater than 5 kg within 3 months before screening
- Obesity caused by other endocrine disorders or diagnosed genetic/syndromic obesity forms
- Previous or planned surgical treatment for obesity (except liposuction or abdominoplasty over 1 year ago)
- Known significant gastric emptying issues like severe gastroparesis
- Poorly controlled high blood pressure at screening
- Recent cardiovascular events within 3 months before screening such as heart attack or stroke
- Use of any GLP-1 receptor agonist therapy 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 as part of the study treatment for weight management.
Weekly visits for up to 72 weeks
Trial Site Locations
Total: 61 locations
1
Lakeview Clinical Research
Guntersville, Alabama, United States, 35976
Actively Recruiting
2
Arizona Clinical Trials
Tucson, Arizona, United States, 85711
Actively Recruiting
3
Orange County Research Center
Lake Forest, California, United States, 92630
Actively Recruiting
4
Ark Clinical Research
Long Beach, California, United States, 90815
Actively Recruiting
5
Catalina Research Institute, LLC
Montclair, California, United States, 91763
Actively Recruiting
6
Prospective Research Innovations Inc.
Rancho Cucamonga, California, United States, 91730
Actively Recruiting
7
Encompass Clinical Research
Spring Valley, California, United States, 91978
Actively Recruiting
8
Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States, 20009
Actively Recruiting
9
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States, 33761
Actively Recruiting
10
Center for Diabetes, Obesity and Metabolism Inc
Pembroke Pines, Florida, United States, 33024
Actively Recruiting
11
Progressive Medical Research
Port Orange, Florida, United States, 32127
Actively Recruiting
12
Eirvera, LLC
St. Petersburg, Florida, United States, 33711
Actively Recruiting
13
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, United States, 31904
Actively Recruiting
14
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States, 30291
Actively Recruiting
15
Elevate Clinical Research
Lake Charles, Louisiana, United States, 70605
Actively Recruiting
16
Centennial Medical Group
Columbia, Maryland, United States, 21045-5840
Actively Recruiting
17
Centricity Research Morehead City Multispeciality
Morehead City, North Carolina, United States, 28557
Actively Recruiting
18
Remington Davis Inc
Columbus, Ohio, United States, 43215
Actively Recruiting
19
Essential Medical Research
Tulsa, Oklahoma, United States, 74137
Actively Recruiting
20
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29405
Actively Recruiting
21
Circle Clinical Research
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
22
Velocity Clinical Research
Dallas, Texas, United States, 75230
Actively Recruiting
23
Juno Research, LLC
Houston, Texas, United States, 77040
Actively Recruiting
24
HRI ? Pasadena, LLC
Pasadena, Texas, United States, 77505
Actively Recruiting
25
DM Clinical Research
Tomball, Texas, United States, 77375
Actively Recruiting
26
Manassas Clinical Research Center
Manassas, Virginia, United States, 20110
Actively Recruiting
27
Centricity Research Suffolk Primary Care
Suffolk, Virginia, United States, 23435
Actively Recruiting
28
Era Health Research
Redmond, Washington, United States, 98052
Actively Recruiting
29
CINME
Buenos Aires, Argentina, C1056ABI
Actively Recruiting
30
CEDIC Centro de Investigaciones Clinicas
Buenos Aires, Argentina, C1060ABN
Actively Recruiting
31
Centro Medico Viamonte SRL
Buenos Aires, Argentina, C1120AAC
Actively Recruiting
32
IME - Instituto Médico Especializado
Buenos Aires, Argentina, C1405BCH
Actively Recruiting
33
Instituto centenario
Ciudad Autonoma Buenos Aires, Argentina, C1204AAD
Actively Recruiting
34
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, Argentina, C1425AGC
Actively Recruiting
35
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, Argentina, B7600FYK
Actively Recruiting
36
Paratus Clinical Western Sydney
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
37
Logan Hospital
Meadowbrook, Queensland, Australia, 4131
Actively Recruiting
38
Baker Heart and Diabetes Insitute
Melbourne, Victoria, Australia, 3004
Actively Recruiting
39
TGElliott Inc. dba BC Diabetes
Vancouver, British Columbia, Canada, V5Y 3W2
Actively Recruiting
40
Centricity Research Brampton Endocrinology
Brampton, Ontario, Canada, L6S 0C6
Actively Recruiting
41
Medicor Research Inc
Greater Sudbury, Ontario, Canada, P3C 1X3
Actively Recruiting
42
LMC Clinical Research Inc
Toronto, Ontario, Canada, M4G 3E8
Actively Recruiting
43
Clinique des maladies lipidiques de Quebec
Québec, Canada, G1V 4W2
Actively Recruiting
44
Kasugai Municipal Hospital
Aichi, Japan, 486-8510
Actively Recruiting
45
Fukuhama Chuo Clinic
Fukuoka, Japan, 810-0066
Actively Recruiting
46
NTT Medical Center Sapporo
Hokkaido, Japan, 060-0061
Actively Recruiting
47
Hasegawa Medicine Clinic
Hokkaido, Japan, 066-0032
Actively Recruiting
48
Higashijujo Sakai Diabetes Internal Medicine Clinic
Tokyo, Japan, 114-0001
Actively Recruiting
49
FDI Clinical Research
San Juan, Puerto Rico, 00927
Actively Recruiting
50
Changhua Christian Hospital
Changhua, Taiwan, 50006
Actively Recruiting
51
Chia-Yi Christian Hospital
Chiayi City, Taiwan, 600
Actively Recruiting
52
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
53
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Actively Recruiting
54
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
55
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
56
National Taiwan University Hospital
Taipei, Taiwan, 10048
Actively Recruiting
57
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
58
Siriraj Hospital
Bangkok, Thailand, 10700
Actively Recruiting
59
Division of Endocrinology and Metabolism;Internal Medicine
Chiang Mai, Thailand, 50200
Actively Recruiting
60
Songklanagarind Hospital
Hat Yai, Thailand, 90110
Actively Recruiting
61
Thammasat University Hospital
Khlong Luang, Thailand, 12120
Actively Recruiting
Research Team
R
Reference Study ID Number: WC45726 https://forpatients.roche.com/
F
Fastest response: use the inquiry form. No email attachments. 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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