Obesity or Overweight
Conditions
Brief summary
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.
Interventions
DRUGRO7795081
RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.
DRUGPlacebo
Placebo matching each RO7795081 dosing regimen arm will be administered orally once daily during the 38-week treatment period.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have at screening: 1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or 2. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in Body Weight From Baseline to Week 30 | Baseline to Week 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Body Weight (kg) from Baseline to Week 38 | Baseline to Week 38 | — |
| Percent Change in Body Weight From Baseline to Week 38 | Baseline to Week 38 | — |
| Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 30 | Baseline and Week 30 | — |
| Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 38 | Baseline and Week 38 | — |
| Absolute Change in BMI (kg/m^2) from Baseline to Week 30 | Baseline to Week 30 | — |
| Absolute Change in Body Weight (kg) from Baseline to Week 30 | Baseline to Week 30 | — |
| Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious AEs (SAEs) | From first dose until 28 days after the final dose of study treatment (42 weeks) | — |
| Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from Baseline to Week 42 | 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). |
| Change in Patient Health Questionnaire-9 (PHQ-9) Scores from Baseline to Week 42 | 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. |
| Plasma Concentrations of RO7795081 at Prespecified Timepoints | Predose on Day 1 and at prespecified timepoints until Week 38 | — |
| Absolute Change in BMI (kg/m^2) from Baseline to Week 38 | Baseline to Week 38 | — |
Countries
United States
Outcome results
None listed