NCT07081958CompletedPhase 2
A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 38 Weeks to Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for chronic weight management in adult participants with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 352 (actual)
- First submitted
- 22 Jul 2025
- Start date
- 29 Jul 2025
- Primary completion date
- 28 Apr 2026
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Obesity
- NCT number
- NCT07081958
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 352
- From 29 Jul 2025 to the primary completion date, 28 Apr 2026
- 36 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or planned surgical treatment for obesity
- 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.
Other illness
- Have a history or diagnosis of any type of diabetes mellitus (Type 1 diabetes \[T1D\], T2D, or rare forms of diabetes)
- Have 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)
- Have poorly controlled hypertension, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension
- Have a history of acute or chronic pancreatitis
- 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), or had a suicide attempt within the last 1 year of screening
Other
- Participation in unbalanced/extreme diets or in an organized weight reduction program within 3 months of the screening visit or planning to engage in such diets or programs during the study
- Have a known, clinically significant gastric emptying abnormality
Who the study is looking for
- Participants must have at screening:
- Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
- BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, cardiovascular disease
- History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
- A stable body weight for the 3 months prior to screening (maximum 5% body weight gain and/or loss)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Accellacare of McFarland Coordinator of this site? Confirm its status | Ames | United States | Unknown status |
| Pinnacle Research Group Coordinator of this site? Confirm its status | Anniston | United States | Unknown status |
| Texas Diabetes & Endocrinology, P.A. Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Apex Mobile Clinical Research Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Internal Medicine and Pediatrics Associates of Bristol Coordinator of this site? Confirm its status | Bristol | United States | Unknown status |
| Mercury Street Medical Group, PLLC Coordinator of this site? Confirm its status | Butte | United States | Unknown status |
| Accellacare of Cary - Cary Medical Group Coordinator of this site? Confirm its status | Cary | United States | Unknown status |
| Neurobehavioral Research, Inc. Coordinator of this site? Confirm its status | Cedarhurst | United States | Unknown status |
| K2 Medical Research WINTER GARDEN Coordinator of this site? Confirm its status | Clermont | United States | Unknown status |
| Velocity Clinical Research Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Accellacare - Hickory Coordinator of this site? Confirm its status | Hickory | United States | Unknown status |
| Juno Research, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Knoxville-Summit-Halls Family Practice Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Accellacare of Knoxville Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Orange County Research Center Coordinator of this site? Confirm its status | Lake Forest | United States | Unknown status |
| K2 Medical Research - Maitland Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Manassas Clinical Research Center Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| Clinical Research Associates Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Alliance for Multispecialty Research, LLC (AMR Norman) Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| Accellacare of Duly Health and Care Coordinator of this site? Confirm its status | Oak Lawn | United States | Unknown status |
| Tristar Clinical Investigations Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Accellacare of Raleigh Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Prospective Research Innovations Inc Coordinator of this site? Confirm its status | Rancho Cucamonga | United States | Unknown status |
| Accellacare of Rocky Mount Coordinator of this site? Confirm its status | Rocky Mount | United States | Unknown status |
| Accellacare of Salisbury Coordinator of this site? Confirm its status | Salisbury | United States | Unknown status |
| Consano Clinical Research Coordinator of this site? Confirm its status | Shavano Park | United States | Unknown status |
| ASCLEPES Research Centers Coordinator of this site? Confirm its status | Sherman Oaks | United States | Unknown status |
| Encompass Clinical Research Coordinator of this site? Confirm its status | Spring Valley | United States | Unknown status |
| Accellacare of Piedmont HealthCare Coordinator of this site? Confirm its status | Statesville | United States | Unknown status |
| Chrysalis Clinical Research Coordinator of this site? Confirm its status | St. George | United States | Unknown status |
| Rophe Adult and Pediatric Medicine/SKYCRNG Coordinator of this site? Confirm its status | Union City | United States | Unknown status |
| Emerson Clinical Research Institute LLC Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Chase Medical Research Coordinator of this site? Confirm its status | Waterbury | United States | Unknown status |
| Accellacare of Wilmington, LLC Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Accellacare Research of Winston Salem Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.