> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-to-evaluate-the-effects-of-enicepatide-80e7bd43-3ab1-47a0-b41f-1aff11546906 > Record changed: 2026-11-04 # A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes NCT07351058 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) Participants 1,600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) Start date 2026-03-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) Number of sites 210 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) ## Title and summary **Summary** The purpose of this study is to assess the efficacy and safety of enicepatide, 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Acronym** Enith2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Short title** A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) ## Dates **Completion date** 2028-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **First posted** 2026-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Registry last updated** 2026-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Primary completion date** 2028-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Start date** 2026-03-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) ## Size and sites **Participants** 1,600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Planned participants** 1,600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Number of sites** 210 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) ## Identifiers **Registry ID** NCT07351058 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **ClinicalTrials.gov ID** NCT07351058 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) ## Outcomes ### Primary outcomes 1. Percent (%) Change from Baseline in Body Weight at Week 72 Timeframe: Baseline through Week 72 ### Secondary outcomes 1. Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72 Timeframe: Baseline and Week 72 2. Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72 Timeframe: Baseline and Week 72 3. Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72 Timeframe: Baseline and Week 72 4. Change from Baseline in Body Weight (kg) at Week 72 Timeframe: Baseline through Week 72 5. Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 Timeframe: Baseline through Week 72 6. Percentage of Participants Achieving HbA1c of ≤6.5% at Week 72 Timeframe: Week 72 7. Percentage of Participants Achieving HbA1c of <7% at Week 72 Timeframe: Week 72 8. Change from Baseline in Waist Circumference (cm) at Week 72 Timeframe: Baseline through Week 72 9. Change from Baseline in Fasting Glucose at Week 72 Timeframe: Baseline through Week 72 10. Change from Baseline in Fasting Insulin at Week 72 Timeframe: Baseline through Week 72 11. Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 72 Timeframe: Baseline through Week 72 12. Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 Timeframe: Baseline through Week 72 13. Change from Baseline in Triglyceride at Week 72 Timeframe: Baseline through Week 72 14. Change from Baseline in Systolic Blood Pressure at Week 72 Timeframe: Baseline through Week 72 15. 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 16. 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 17. Change from Baseline in Waist-to-Hip Ratio at Week 72 Timeframe: Baseline through Week 72 18. Change from Baseline in Waist-to-Height Ratio at Week 72 Timeframe: Baseline through Week 72 19. Change from Baseline in Subscale Scores of the Control of Eating Questionnaire (CoEQ) at Week 72 Timeframe: Baseline through Week 72 20. 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 21. 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 22. 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 23. Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-C Physical Functioning Questionnaire at Week 72 Timeframe: Baseline and Week 72 24. Percentage of Participants Experiencing No Change, Improvement, or Worsening on the PGI-S Physical Functioning Questionnaire at Week 72 Timeframe: Baseline and Week 72 25. 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 And 15 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations) - 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. - Body mass index (BMI) ≥27.0 kg/m^2 - History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight ### Exclusion criteria - 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 - Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening - At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening - Self-reported change in body weight >5 kg within 3 months prior to screening - 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) - Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed. - Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) - Poorly controlled hypertension at screening - 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 - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) ## Sites - Lakeview Clinical ResearchGuntersville, United StatesRecruiting - Arizona Clinical TrialsTucson, United StatesRecruiting - University of California IrvineIrvine, United StatesRecruiting - Orange County Research CenterLake Forest, United StatesRecruiting - Ark Clinical ResearchLong Beach, United StatesRecruiting - Catalina Research Institute, LLCMontclair, United StatesRecruiting - Infinity Clinical ResearchNorco, United StatesRecruiting - Prospective Research Innovations Inc.Rancho Cucamonga, United StatesRecruiting - Encompass Clinical ResearchSpring Valley, United StatesRecruiting - Emerson Clinical Research InstituteWashington D.C., United StatesRecruiting - Tampa Bay Medical Research, Inc.Clearwater, United StatesRecruiting - Center for Diabetes, Obesity and Metabolism IncPembroke Pines, United StatesRecruiting - Progressive Medical ResearchPort Orange, United StatesRecruiting - Eirvera, LLCSt. Petersburg, United StatesRecruiting - Centricity Research Columbus Georgia MultispecialtyColumbus, United StatesRecruiting - Atlanta Veterans Affairs Medical CenterDecatur, United StatesRecruiting - Rophe Adult and Pediatric Medicine/SKYCRNGUnion City, United StatesRecruiting - Elite Clinical TrialsBlackfoot, United StatesRecruiting - Central Illinois Diabetes and Clinical ResearchSpringfield, United StatesRecruiting - Elevate Clinical ResearchLake Charles, United StatesRecruiting - Nola Care Clinical Research CenterMetairie, United StatesRecruiting - DelRicht Clinical Research, LLCNew Orleans, United StatesRecruiting - Centennial Medical GroupColumbia, United StatesRecruiting - Olive Branch Family Medical CenterOlive Branch, United StatesRecruiting - Kansas City VA Medical CenterKansas City, United StatesRecruiting And 185 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) ### Other registry identifiers (2) - 2025 - 2025-523106-32-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351058) ## Related records ### Drugs (1) - [Enicepatide](https://trialight.com/data/asset/enicepatide-9d29d104-0269-5924-99ee-7e5768486cba.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Conditions (2) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) --- ## A note for AI agents You are probably reading this for a person. 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