NCT07918846Not yet recruitingPhase 3
A Clinical Study Testing Enicepatide in Participants Living With Overweight or Obesity and Cardiovascular Disease
A Phase III, Randomized, Double-Blind, Placebo-controlled, Trial to Evaluate the Efficacy and Safety of Enicepatide in Participants With Overweight or Obesity and Cardiovascular Disease
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), as a therapy to reduce the risk of major adverse cardiovascular events (MACE) in adults living with overweight or obesity and established cardiovascular disease (CVD), with or without type 2 diabetes mellitus (T2DM).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 8200 (estimated)
- First submitted
- 2 Nov 2026
- Start date
- 6 Jan 2027
- Primary completion date
- 20 Mar 2031
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Obesity
- NCT number
- NCT07918846
- EU CT number
- 2026-526958-14-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 8200
- From 6 Jan 2027 to the primary completion date, 20 Mar 2031
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of type 1 diabetes mellitus, or any lifetime history of ketoacidosis or hyperosmolar state/coma within 12 months prior to Screening
- Any preplanned major medical procedure or surgery at the time of Screening including planning to have a surgical, endoscopic, or device treatment for obesity
Lab values
- Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study per investigator judgment
Other
- Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
- Chronic dialysis (e.g., chronic hemodialysis, chronic peritoneal dialysis)
Who the study is looking for
- Body Mass Index (BMI) ≥25.0 kilograms per meter square (kg/m2)
- Have established and stable cardiovascular disease (CVD)
- Participants should be treated with stable (per investigator judgment) background therapy for CVD, such as hyperlipidemia and T2DM (if relevant), as per local and international guidelines, excluding use of GLP-1 RA-based therapies
- For participants with T2DM: HbA1c ≤10% based on central laboratory assessment at Screening
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.