Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:43 AM
Study NCT ID:
NCT07351058
Status:
RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-08-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-01-16', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent (%) Change from Baseline in Body Weight at Week 72', 'timeFrame': 'Baseline through Week 72'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Change from Baseline in Body Weight (kg) at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Percentage of Participants Achieving HbA1c of ≤6.5% at Week 72', 'timeFrame': 'Week 72'}, {'measure': 'Percentage of Participants Achieving HbA1c of <7% at Week 72', 'timeFrame': 'Week 72'}, {'measure': 'Change from Baseline in Waist Circumference (cm) at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Fasting Glucose at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Fasting Insulin at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Triglyceride at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Systolic Blood Pressure at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in the Physical Functioning Domain Score of the Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Physical Functioning Composite Score of the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Waist-to-Hip Ratio at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Waist-to-Height Ratio at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Subscale Scores of the Control of Eating Questionnaire (CoEQ) at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Symptoms and Impact of Urinary Incontinence as Assessed by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Percentage of Participants Experiencing No Change, Improvement, or Worsening on the Patient Global Impression of Change (PGI-C) Urinary Incontinence Questionnaire at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percentage of Participants Experiencing No Change, Improvement, or Worsening on the Patient Global Impression of Severity (PGI-S) Urinary Incontinence Questionnaire at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-C Physical Functioning Questionnaire at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-S Physical Functioning Questionnaire at Week 72', 'timeFrame': 'Baseline and Week 72'}, {'measure': 'Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Form Domain Scores and Component Summary Scores at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Domain Scores and Total Score at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Non-HDL Cholesterol at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in VLDL Cholesterol at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Total Cholesterol at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Free Fatty Acids at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Diastolic Blood Pressure at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in High-Sensitivity C-reactive Protein (hsCRP) at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Urinary Albumin/Creatinine Ratio at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in Body Mass Index (BMI) at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Percent (%) Change from Baseline in Body Weight by Obesity Class at Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Time to Achieve ≥5%, ≥10%, or ≥15% Body Weight Loss from Baseline Through Week 72', 'timeFrame': 'From Baseline through Week 72'}, {'measure': 'Percentage of Participants Achieving HbA1c of <5.7% at Week 72', 'timeFrame': 'Week 72'}, {'measure': 'Incidence and Severity of Adverse Events, with Severity Determined According to Mild/Moderate/Severe Criteria', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score Through Week 72', 'timeFrame': 'Baseline through Week 72'}, {'measure': 'Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score Through Week 72', 'timeFrame': 'Baseline through Week 72'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity or Overweight', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of RO7795068, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)\n* Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.\n* Body mass index (BMI) ≥27.0 kg/m\\^2\n* History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight\n\nExclusion Criteria:\n\n* History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening\n* Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening\n* At least 2 confirmed fasting blood glucose values \\>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening\n* Self-reported change in body weight \\>5 kg within 3 months prior to screening\n* 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* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.\n* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)\n* Poorly controlled hypertension at screening\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* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization"}, 'identificationModule': {'nctId': 'NCT07351058', 'acronym': 'Enith2', 'briefTitle': 'A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'WC45726'}, 'secondaryIdInfos': [{'id': '2025-523106-32-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 1: Placebo', 'interventionNames': ['Combination Product: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: RO7795068 Dosing Regimen 1', 'interventionNames': ['Combination Product: RO7795068']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: RO7795068 Dosing Regimen 2', 'interventionNames': ['Combination Product: RO7795068']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: RO7795068 Dosing Regimen 3', 'interventionNames': ['Combination Product: RO7795068']}], 'interventions': [{'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.', 'armGroupLabels': ['Arm 1: Placebo']}, {'name': 'RO7795068', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['CT-388', 'RG6640'], 'description': 'RO7795068 will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.', 'armGroupLabels': ['Arm 2: RO7795068 Dosing Regimen 1', 'Arm 3: RO7795068 Dosing Regimen 2', 'Arm 4: RO7795068 Dosing Regimen 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90815', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ark Clinical Research', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Progressive Medical Research', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Remington Davis Inc', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Reference Study ID Number: WC45726 https://forpatients.roche.com/', 'role': 'CONTACT', 'email': 'global-roche-genentech-trials@gene.com', 'phone': '888-662-6728 (U.S. Only)'}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "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"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}