Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT07081958
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2025-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-07-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Body Weight From Baseline to Week 30', 'timeFrame': 'Baseline to Week 30'}], 'secondaryOutcomes': [{'measure': 'Absolute Change in Body Weight (kg) from Baseline to Week 30', 'timeFrame': 'Baseline to Week 30'}, {'measure': 'Absolute Change in Body Weight (kg) from Baseline to Week 38', 'timeFrame': 'Baseline to Week 38'}, {'measure': 'Percent Change in Body Weight From Baseline to Week 38', 'timeFrame': 'Baseline to Week 38'}, {'measure': 'Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 30', 'timeFrame': 'Baseline and Week 30'}, {'measure': 'Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 38', 'timeFrame': 'Baseline and Week 38'}, {'measure': 'Absolute Change in BMI (kg/m^2) from Baseline to Week 30', 'timeFrame': 'Baseline to Week 30'}, {'measure': 'Absolute Change in BMI (kg/m^2) from Baseline to Week 38', 'timeFrame': 'Baseline to Week 38'}, {'measure': 'Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious AEs (SAEs)', 'timeFrame': 'From first dose until 28 days after the final dose of study treatment (42 weeks)'}, {'measure': 'Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from Baseline to Week 42', 'timeFrame': 'Baseline to Week 42', 'description': '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).'}, {'measure': 'Change in Patient Health Questionnaire-9 (PHQ-9) Scores from Baseline to Week 42', 'timeFrame': 'Baseline to Week 42', 'description': '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.'}, {'measure': 'Plasma Concentrations of RO7795081 at Prespecified Timepoints', 'timeFrame': 'Predose on Day 1 and at prespecified timepoints until Week 38'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity or Overweight']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must have at screening:\n\n 1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\\^2; or\n 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\n* History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight\n* A stable body weight for the 3 months prior to screening (maximum 5% body weight gain and/or loss)\n\nExclusion Criteria:\n\n* Have a history or diagnosis of any type of diabetes mellitus (Type 1 diabetes \\[T1D\\], T2D, or rare forms of diabetes)\n* 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)\n* 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\n* Prior or planned surgical treatment for obesity\n* Have a known, clinically significant gastric emptying abnormality\n* Have poorly controlled hypertension, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension\n* 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.\n* Have a history of acute or chronic pancreatitis\n* 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"}, 'identificationModule': {'nctId': 'NCT07081958', 'briefTitle': 'A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BP45702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 1: Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: RO7795081 Dosing Regimen 1', 'interventionNames': ['Drug: RO7795081']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: RO7795081 Dosing Regimen 2', 'interventionNames': ['Drug: RO7795081']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: RO7795081 Dosing Regimen 3', 'interventionNames': ['Drug: RO7795081']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5: RO7795081 Dosing Regimen 4', 'interventionNames': ['Drug: RO7795081']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6: RO7795081 Dosing Regimen 5', 'interventionNames': ['Drug: RO7795081']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 7: RO7795081 Dosing Regimen 6', 'interventionNames': ['Drug: RO7795081']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 8: RO7795081 Dosing Regimen 7', 'interventionNames': ['Drug: RO7795081']}], 'interventions': [{'name': 'RO7795081', 'type': 'DRUG', 'otherNames': ['CT-996', 'RG6652'], 'description': 'RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.', 'armGroupLabels': ['Arm 2: RO7795081 Dosing Regimen 1', 'Arm 3: RO7795081 Dosing Regimen 2', 'Arm 4: RO7795081 Dosing Regimen 3', 'Arm 5: RO7795081 Dosing Regimen 4', 'Arm 6: RO7795081 Dosing Regimen 5', 'Arm 7: RO7795081 Dosing Regimen 6', 'Arm 8: RO7795081 Dosing Regimen 7']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matching each RO7795081 dosing regimen arm will be administered orally once daily during the 38-week treatment period.', 'armGroupLabels': ['Arm 1: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '92630', 'city': 'Lake Forest', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.64697, 'lon': -117.68922}}, {'zip': '91730', 'city': 'Rancho Cucamonga', 'state': 'California', 'country': 'United States', 'facility': 'Prospective Research Innovations Inc.', 'geoPoint': {'lat': 34.1064, 'lon': -117.59311}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Asclepes Research Centers', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'Encompass Clinical 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