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Not yet recruitingNCT07918846Enith-MACEUpdated Nov 5, 2026

A Clinical Study Testing Enicepatide in Participants Living With Overweight or Obesity and Cardiovascular Disease

A Phase 3 interventional study of Enicepatide and Placebo in Overweight, Obesity and Cardiovascular Disease, sponsored by Hoffmann-La Roche. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
8,200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Overweight
  • Obesity
  • Cardiovascular Disease

Browse trials for

03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 8,200 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Browse Hoffmann-La Roche studies →

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (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: ≤10% based on central laboratory assessment at Screening

Exclusion criteria

Exclusion Criteria:

  • History of type 1 diabetes mellitus, or any lifetime history of ketoacidosis or hyperosmolar state/coma within 12 months prior to Screening
  • 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
  • Any preplanned major medical procedure or surgery at the time of Screening including planning to have a surgical, endoscopic, or device treatment for obesity
  • Known gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
  • Chronic dialysis (e.g., chronic hemodialysis, chronic peritoneal dialysis)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
8,200 participants (estimated)

Study arms

  • Placebo comparator
    Arm 1: Placebo

    Participants will receive volume-matched placebo.

    Combination Product: Placebo

  • Experimental
    Arm 2: Enicepatide

    Participants will receive enicepatide.

    Combination Product: Enicepatide

Interventions

  • Combination productEnicepatide

    Participants will receive enicepatide as per the schedule described in the protocol.

    Also known as: RO7795068, CT-388, RG6640

  • Combination productPlacebo

    Participants will receive volume-matched placebo as per the schedule described in the protocol.

06

What researchers measure

Primary outcomes

  1. Time to First Occurrence of Any Component of 5-point (5P) MACE

    The components of this composite 5P MACE endpoint consist of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for heart failure (HHF) or urgent heart failure (HF) visit, or urgent coronary revascularization.

    Time frame: From randomization up to 4.2 years

Secondary outcomes

  1. Time to First Occurrence of Any Component of 3-point (3P) MACE

    The components of this composite 3P MACE endpoint consist of CV death, non-fatal MI or non-fatal stroke.

    Time frame: From randomization up to 4.2 years

  2. Time to New-Onset T2DM

    Time frame: From randomization up to 4.2 years

  3. Total Occurrence of All-Cause Hospitalization

    Time frame: From randomization up to 4.2 years

  4. Time to Death From Any Cause

    Time frame: From randomization up to 4.2 years

  5. Time to CV Death

    Time frame: From randomization up to 4.2 years

  6. Incidence and Severity of Adverse Events

    Time frame: From baseline up to 4.2 years

  7. Time to First Occurrence of Any Component of 4-point (4P) MACE

    The components of this composite 4P MACE endpoint consist of CV death, non-fatal MI, non-fatal stroke, or HHF or urgent HF visit.

    Time frame: From randomization up to 4.2 years

  8. Time to First Occurrence of HHF, Urgent HF Visit, or CV Death

    Time frame: From randomization up to 4.2 years

  9. Time to First Occurrence of HHF, Urgent HF Visit, or All-Cause Mortality

    Time frame: From randomization up to 4.2 years

  10. Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Short Form 36 Health Survey Version 2.0 (SF-36 V2) Acute Form Physical Functioning Domain Score

    Time frame: From baseline through Week 48

  11. Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Role-Physical Domain Score

    Time frame: From baseline through Week 48

  12. Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Bodily Pain Domain Score

    Time frame: From baseline through Week 48

  13. Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form General Health Domain Score

    Time frame: From baseline through Week 48

  14. Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Vitality Domain Score

    Time frame: From baseline through Week 48

  15. Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Social Functioning Domain Score

    Time frame: From baseline through Week 48

  16. Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Role-Emotional Domain Score

    Time frame: From baseline through Week 48

  17. Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Mental Health Domain Score

    Time frame: From baseline through Week 48

  18. Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Physical Component Summary Score

    Time frame: From baseline through Week 48

  19. Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Mental Component Summary Score

    Time frame: From baseline through Week 48

  20. Change From Baseline in Health Status as Assessed by the EuroQol-5 Dimensions 5-Level (EQ-5D-5L) Score

    Time frame: From baseline through Week 48

  21. Time To First Occurrence of Sustained ≥40% Estimated Glomerular Filtration Rate (eGFR) Decline From Baseline, End Stage Kidney Disease (ESKD), or Renal Death

    Time frame: From randomization up to 4.2 years

  22. Change From Baseline in Body Weight

    Time frame: From baseline through the end of study (up to 4.2 years)

  23. Change From Baseline in Waist Circumference

    Time frame: From baseline through the end of study (up to 4.2 years)

  24. Change From Baseline in Waist-to-Height Ratio

    Time frame: From baseline through the end of study (up to 4.2 years)

  25. Change From Baseline in Systolic Blood Pressure

    Time frame: From baseline through the end of study (up to 4.2 years)

  26. Change From Baseline in Diastolic Blood Pressure

    Time frame: From baseline through the end of study (up to 4.2 years)

  27. Change From Baseline in Heart Rate

    Time frame: From baseline through the end of study (up to 4.2 years)

  28. Change From Baseline in Double Product

    Double product is defined as heart rate multiplied by systolic blood pressure.

    Time frame: From baseline through the end of study (up to 4.2 years)

  29. Change From Baseline in Pulse Pressure

    Time frame: From baseline through the end of study (up to 4.2 years)

  30. Change From Baseline in Mean Arterial Pressure

    Time frame: From baseline through the end of study (up to 4.2 years)

  31. Change From Baseline in Total Cholesterol

    Time frame: From baseline through the end of study (up to 4.2 years)

  32. Change From Baseline in Non-High-Density Lipoprotein (HDL)

    Time frame: From baseline through the end of study (up to 4.2 years)

  33. Change From Baseline in Low-Density Lipoprotein (LDL)

    Time frame: From baseline through the end of study (up to 4.2 years)

  34. Change From Baseline in HDL

    Time frame: From baseline through the end of study (up to 4.2 years)

  35. Change From Baseline in Triglycerides (TG)

    Time frame: From baseline through the end of study (up to 4.2 years)

  36. Change From Baseline in Very-low-Density Lipoprotein (vLDL)

    Time frame: From baseline through the end of study (up to 4.2 years)

  37. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: From baseline through the end of study (up to 4.2 years)

  38. Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)

    Time frame: From baseline through the end of study (up to 4.2 years)

  39. Change From Baseline in N-Terminal pro-B-Type Natriuretic Peptide (NT-proBNP)

    Time frame: From baseline through the end of study (up to 4.2 years)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07918846
Lead sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical
Responsible party
Sponsor
First posted
Nov 5, 2026
Start date
Jan 6, 2027 (estimated)
Primary completion
Mar 20, 2031 (estimated)
Completion
Apr 17, 2031 (estimated)
Last update
Nov 5, 2026

Study contacts

Reference Study ID Number: WC46385 https://forpatients.roche.com/ No attachments to email below
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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