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NCT Number: NCT07081958

A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity or Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pinnacle Research Group, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)
  • 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
  • Prior or planned surgical treatment for obesity
  • Have a known, clinically significant gastric emptying abnormality
  • Have poorly controlled hypertension, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension
  • 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.
  • 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

Treatment and study plan

RO7795081

Drug

RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.

Other names: CT-996, RG6652

Placebo

Drug

Placebo matching each RO7795081 dosing regimen arm will be administered orally once daily during the 38-week treatment period.

Primary outcomes

  1. Percent Change in Body Weight From Baseline to Week 30

    Time frame: Baseline to Week 30

Secondary outcomes

  1. Absolute Change in Body Weight (kg) from Baseline to Week 30

    Time frame: Baseline to Week 30

  2. Absolute Change in Body Weight (kg) from Baseline to Week 38

    Time frame: Baseline to Week 38

  3. Percent Change in Body Weight From Baseline to Week 38

    Time frame: Baseline to Week 38

  4. Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 30

    Time frame: Baseline and Week 30

  5. Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 38

    Time frame: Baseline and Week 38

  6. Absolute Change in BMI (kg/m^2) from Baseline to Week 30

    Time frame: Baseline to Week 30

  7. Absolute Change in BMI (kg/m^2) from Baseline to Week 38

    Time frame: Baseline to Week 38

  8. Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious AEs (SAEs)

    Time frame: From first dose until 28 days after the final dose of study treatment (42 weeks)

  9. Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from Baseline to Week 42

    Time frame: Baseline to Week 42

    The C-SSRS is an assessment tool to evaluate suicidal ideation and behavior during the assessment period via a participant-reported questionnaire comprising 2 to 6 questions (yes or no). Affirmative responses count as 1 point, which are then summed to indicate the level of suicide risk on a scale of 0 (no risk) to 6 (high risk).

  10. Change in Patient Health Questionnaire-9 (PHQ-9) Scores from Baseline to Week 42

    Time frame: Baseline to Week 42

    PHQ-9 is a 9-item patient reported outcome (PRO) used to assess severity of depression. Responses are rated based on the frequency of symptoms on a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). A PHQ-9 total score ranging from 0 to 27 can be calculated by summing the nine items; a higher score corresponds with more severe depression.

  11. Plasma Concentrations of RO7795081 at Prespecified Timepoints

    Time frame: Predose on Day 1 and at prespecified timepoints until Week 38

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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