> 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-9320d268-0982-4627-8819-c593b49afd4f > Record changed: 2026-11-04 # A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes NCT07351045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) Participants 2,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) Start date 2026-03-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) Number of sites 209 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) ## 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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Acronym** Enith1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Short title** A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **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 Without Type 2 Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) ## Dates **Completion date** 2028-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **First posted** 2026-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Registry last updated** 2026-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Primary completion date** 2028-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Start date** 2026-03-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) ## Size and sites **Participants** 2,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Planned participants** 2,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Number of sites** 209 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) ## Identifiers **Registry ID** NCT07351045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **ClinicalTrials.gov ID** NCT07351045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) ## 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/NCT07351045) ## 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. Percentage of Participants Achieving ≥20% Body Weight Loss from Baseline at Week 72 Timeframe: Baseline and Week 72 5. Percentage of Participants Achieving ≥25% Body Weight Loss from Baseline at Week 72 Timeframe: Baseline and Week 72 6. Change from Baseline in Body Weight (kg) at Week 72 Timeframe: Baseline through Week 72 7. Change from Baseline in Waist Circumference (cm) at Week 72 Timeframe: Baseline through Week 72 8. Change from Baseline in Fasting Glucose at Week 72 Timeframe: Baseline through Week 72 9. Change from Baseline in Fasting Insulin at Week 72 Timeframe: Baseline through Week 72 10. Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 72 Timeframe: Baseline through Week 72 11. Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 Timeframe: Baseline through Week 72 12. Change from Baseline in Triglyceride at Week 72 Timeframe: Baseline through Week 72 13. Change from Baseline in Systolic Blood Pressure at Week 72 Timeframe: Baseline through Week 72 14. 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 15. 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 16. Change from Baseline in Waist-to-Hip Ratio at Week 72 Timeframe: Baseline through Week 72 17. Change from Baseline in Waist-to-Height Ratio at Week 72 Timeframe: Baseline through Week 72 18. Percentage of Participants Achieving Normoglycemia (HbA1c <5.7%) at Week 72 Timeframe: Baseline and 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 18 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease - History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight - Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations) ### Exclusion criteria - History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since. - 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) - History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening. - Poorly controlled hypertension at screening - 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 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). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication. - 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/NCT07351045) ## Sites - Pinnacle Research GroupAnniston, United StatesRecruiting - Alabama Clinical TherapeuticsBirmingham, United StatesRecruiting - University of Alabama at BirminghamBirmingham, United StatesRecruiting - Arizona Clinical TrialsTucson, United StatesRecruiting - University of California IrvineIrvine, United StatesRecruiting - Artemis Institute for Clinical Research, LLCSan Diego, United StatesRecruiting - Diablo Clinical Research, Inc.Walnut Creek, United StatesRecruiting - Yale UniversityNew Haven, United StatesRecruiting - Rophe Adult and Pediatric Medicine/SKYCRNGUnion City, United StatesRecruiting - East-West Medical Research InstituteHonolulu, United StatesRecruiting - Elevate Clinical ResearchGurnee, United StatesRecruiting - KnownwellSchaumburg, United StatesRecruiting - Endeavor HealthSkokie, United StatesRecruiting - Monroe Biomedical ResearchLouisville, United StatesRecruiting - Ascension DePaul HealthNew Orleans, United StatesRecruiting - Baltimore VA Medical CenterBaltimore, United StatesRecruiting - Johns Hopkins University School of NursingBaltimore, United StatesRecruiting - Boston Medical CenterBoston, United StatesRecruiting - KnownwellNeedham, United StatesRecruiting - International Diabetes Center At Park NicolletMinneapolis, United StatesRecruiting - DelRicht Research at Gulfport MemorialGulfport, United StatesRecruiting - Clinvest Research LLCSpringfield, United StatesRecruiting - Rochester Clinical ResearchBuffalo, United StatesRecruiting - Hometown Urgent Care and Research - DaytonDayton, United StatesRecruiting - Delricht Research of Tulsa Clinical TrialsTulsa, United StatesRecruiting And 184 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) ### Other registry identifiers (2) - 2025 - 2025-523104-71-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07351045) ## 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 (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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