A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

NCT07351045
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
2,000
clinicaltrials.gov
Lead sponsor
Hoffmann-La Roche
clinicaltrials.gov
Start date
2026-03-16
clinicaltrials.gov
Number of sites
209
clinicaltrials.gov

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.
clinicaltrials.gov
Acronym
Enith1
clinicaltrials.gov
Short title
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
clinicaltrials.gov
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
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2028-08-28
clinicaltrials.gov
First posted
2026-01-20
clinicaltrials.gov
Registry last updated
2026-10-13
clinicaltrials.gov
Primary completion date
2028-07-24
clinicaltrials.gov
Start date
2026-03-16
clinicaltrials.gov

Participants
2,000
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
2,000
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
209
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Hoffmann-La Roche
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07351045
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07351045
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent (%) Change from Baseline in Body Weight at Week 72

    Timeframe: Baseline through Week 72

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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)

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2025
  • 2025-523104-71-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)