A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

NCT07351058
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
1,600
clinicaltrials.gov
Lead sponsor
Hoffmann-La Roche
clinicaltrials.gov
Start date
2026-03-23
clinicaltrials.gov
Number of sites
210
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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).
clinicaltrials.gov
Acronym
Enith2
clinicaltrials.gov
Short title
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and 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 and 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
2028-08-07
clinicaltrials.gov
First posted
2026-01-20
clinicaltrials.gov
Registry last updated
2026-10-13
clinicaltrials.gov
Primary completion date
2028-08-07
clinicaltrials.gov
Start date
2026-03-23
clinicaltrials.gov

Participants
1,600
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
1,600
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
210
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
NCT07351058
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07351058
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. 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
clinicaltrials.gov

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

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2025
  • 2025-523106-32-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)