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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

Full criteria on ClinicalTrials.gov

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Accellacare of McFarland
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AmesUnited StatesUnknown status
Pinnacle Research Group
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AnnistonUnited StatesUnknown status
Texas Diabetes & Endocrinology, P.A.
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AustinUnited StatesUnknown status
Apex Mobile Clinical Research
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BellaireUnited StatesUnknown status
Internal Medicine and Pediatrics Associates of Bristol
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BristolUnited StatesUnknown status
Mercury Street Medical Group, PLLC
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ButteUnited StatesUnknown status
Accellacare of Cary - Cary Medical Group
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CaryUnited StatesUnknown status
Neurobehavioral Research, Inc.
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CedarhurstUnited StatesUnknown status
K2 Medical Research WINTER GARDEN
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ClermontUnited StatesUnknown status
Velocity Clinical Research
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DallasUnited StatesUnknown status
Accellacare - Hickory
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HickoryUnited StatesUnknown status
Juno Research, LLC
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HoustonUnited StatesUnknown status
Knoxville-Summit-Halls Family Practice
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KnoxvilleUnited StatesUnknown status
Alliance for Multispecialty Research, LLC
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KnoxvilleUnited StatesUnknown status
Accellacare of Knoxville
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KnoxvilleUnited StatesUnknown status
Orange County Research Center
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Lake ForestUnited StatesUnknown status
K2 Medical Research - Maitland
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MaitlandUnited StatesUnknown status
Manassas Clinical Research Center
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ManassasUnited StatesUnknown status
Clinical Research Associates
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NashvilleUnited StatesUnknown status
Alliance for Multispecialty Research, LLC (AMR Norman)
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NormanUnited StatesUnknown status
Accellacare of Duly Health and Care
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Oak LawnUnited StatesUnknown status
Tristar Clinical Investigations
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PhiladelphiaUnited StatesUnknown status
Accellacare of Raleigh
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RaleighUnited StatesUnknown status
Prospective Research Innovations Inc
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Rancho CucamongaUnited StatesUnknown status
Accellacare of Rocky Mount
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Rocky MountUnited StatesUnknown status
Accellacare of Salisbury
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SalisburyUnited StatesUnknown status
Consano Clinical Research
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Shavano ParkUnited StatesUnknown status
ASCLEPES Research Centers
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Sherman OaksUnited StatesUnknown status
Encompass Clinical Research
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Spring ValleyUnited StatesUnknown status
Accellacare of Piedmont HealthCare
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StatesvilleUnited StatesUnknown status
Chrysalis Clinical Research
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St. GeorgeUnited StatesUnknown status
Rophe Adult and Pediatric Medicine/SKYCRNG
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Union CityUnited StatesUnknown status
Emerson Clinical Research Institute LLC
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Washington D.C.United StatesUnknown status
Chase Medical Research
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WaterburyUnited StatesUnknown status
Accellacare of Wilmington, LLC
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WilmingtonUnited StatesUnknown status
Accellacare Research of Winston Salem
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.