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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Placebo | Placebo Comparator |
| |
| Arm 2: RO7795081 Dosing Regimen 1 | Experimental |
| |
| Arm 3: RO7795081 Dosing Regimen 2 | Experimental |
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| Arm 4: RO7795081 Dosing Regimen 3 | Experimental |
| |
| Arm 5: RO7795081 Dosing Regimen 4 | Experimental |
| |
| Arm 6: RO7795081 Dosing Regimen 5 | Experimental |
| |
| Arm 7: RO7795081 Dosing Regimen 6 | Experimental |
| |
| Arm 8: RO7795081 Dosing Regimen 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7795081 | Drug | RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight From Baseline to Week 30 | Baseline to Week 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Body Weight (kg) from Baseline to Week 30 | Baseline to Week 30 | |
| Absolute Change in Body Weight (kg) from Baseline to Week 38 | Baseline to Week 38 | |
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Inclusion Criteria:
Participants must have at screening:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| Orange County Research Center |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Experimental |
|
|
| Placebo | Drug | Placebo matching each RO7795081 dosing regimen arm will be administered orally once daily during the 38-week treatment period. |
|
| 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 BMI (kg/m^2) from Baseline to Week 38 | Baseline to Week 38 |
| 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 | 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). | Baseline to Week 42 |
| Change in Patient Health Questionnaire-9 (PHQ-9) Scores from 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. | Baseline to Week 42 |
| Plasma Concentrations of RO7795081 at Prespecified Timepoints | Predose on Day 1 and at prespecified timepoints until Week 38 |
| Lake Forest |
| California |
| 92630 |
| United States |
| Prospective Research Innovations Inc. | Rancho Cucamonga | California | 91730 | United States |
| Asclepes Research Centers | Sherman Oaks | California | 91403 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Chase Medical Research | Waterbury | Connecticut | 06708-3346 | United States |
| Emerson Clinical Research Institute LLC | Washington D.C. | District of Columbia | 20009 | United States |
| K2 Medical Research-Winter Garden | Clermont | Florida | 34711 | United States |
| K2 Medical Research-Maitland | Maitland | Florida | 32751 | United States |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | United States |
| Accellacare of Duly Health and Care | Oak Lawn | Illinois | 60453 | United States |
| McFarland Clinic under Accellacare | Ames | Iowa | 50010 | United States |
| Mercury Street Medical Group, PLLC | Butte | Montana | 59701 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Accellacare of Cary | Cary | North Carolina | 27518 | United States |
| Accellacare - Hickory | Hickory | North Carolina | 28601 | United States |
| Accellacare of Raleigh | Raleigh | North Carolina | 27609 | United States |
| Accellacare of Rocky Mount | Rocky Mount | North Carolina | 27804 | United States |
| Accellacare of Salisbury | Salisbury | North Carolina | 28144 | United States |
| Accellacare of Piedmont Healthcare | Statesville | North Carolina | 28625 | United States |
| Accellacare of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| Accellacare Research of Winston Salem | Winston-Salem | North Carolina | 27103 | United States |
| Alliance for Multispecialty Research, LLC (AMR Norman) | Norman | Oklahoma | 73069 | United States |
| Tristar Clinical Investigations | Philadelphia | Pennsylvania | 19114 | United States |
| Internal Medicine and Pediatrics Associates of Bristol | Bristol | Tennessee | 37620 | United States |
| Alliance for Multispecialty Research. LLC | Knoxville | Tennessee | 37909 | United States |
| Accellacare of Knoxville | Knoxville | Tennessee | 37912 | United States |
| Knoxville-Summit-Halls Family Practice | Knoxville | Tennessee | 37938 | United States |
| Clinical Research Associates | Nashville | Tennessee | 37203 | United States |
| Texas Diabetes & Endocrinology, P.A. | Austin | Texas | 78731 | United States |
| Apex Mobile Clinical Research | Bellaire | Texas | 77401 | United States |
| Velocity Clinical Research | Dallas | Texas | 75230 | United States |
| Juno Research, LLC | Houston | Texas | 77040 | United States |
| Consano Clinical Research | Shavano Park | Texas | 78231 | United States |
| Chrysalis Clinical Research | St. George | Utah | 84790 | United States |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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