Enith-MACE

Not 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

Lead sponsor

Hoffmann-La Roche

Asset

CT-388

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

8,200

Study population

Cardiovascular disease, Obesity / overweight

Eligibility highlights

•BMI ≥25•Established CVD•HbA1c ≤10%

Primary endpoint

•First Occurrence of Any Component of 5-point (5P) MACE

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07918846

Org study IDWC46385

Secondary ID2026-526958-14-00

Timeline

Milestones

Study first posted2026-11-05actual

Last update posted2026-11-05actual

Study start2027-01-06estimated

Primary completion2031-03-20estimated

Study completion2031-04-17estimated

Assets

Investigational agents

CT-388

Who this study enrolls

Cardiovascular diseaseObesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

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 clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)

•Chronic dialysis (e.g., chronic hemodialysis, chronic peritoneal dialysis)

Endpoints (40)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Cardiometabolic biomarkers

Cardiovascular outcomes

Other (unclassified)

Weight & body composition

Heart failure

Other clinical outcomes

Glycemic / diabetes

Renal / kidney

Safety / tolerability / PK

Cardiovascular outcomes

4 endpoints

Primary/protocol endpoint

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

Time frame:From randomization up to 4.2 years

time to event, event

Secondary/protocol endpoint

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

Time frame:From randomization up to 4.2 years

time to event, event

Secondary/protocol endpoint

Time to CV Death

Time frame:From randomization up to 4.2 years

time to event, event

Secondary/protocol endpoint

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

Time frame:From randomization up to 4.2 years

time to event, event

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change From Baseline in Body Weight

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist-to-Height Ratio

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

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

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

change from baseline, improvement

Heart failure

3 endpoints

Secondary/protocol endpoint

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

Time frame:From randomization up to 4.2 years

time to event, event

Secondary/protocol endpoint

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

Time frame:From randomization up to 4.2 years

time to event, event

Secondary/protocol endpoint

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)

change from baseline, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint

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

threshold achievement, improvement

Cardiometabolic biomarkers

10 endpoints

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Heart Rate

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Pulse Pressure

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Total Cholesterol

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

change from baseline, improvement

Secondary/protocol endpoint

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

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Low-Density Lipoprotein (LDL)

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in HDL

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Triglycerides (TG)

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

change from baseline, improvement

Secondary/protocol endpoint

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)

change from baseline, improvement

Patient-reported / QoL

11 endpoints

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From baseline through Week 48

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Incidence and Severity of Adverse Events

Time frame:From baseline up to 4.2 years

descriptive

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Total Occurrence of All-Cause Hospitalization

Time frame:From randomization up to 4.2 years

descriptive

Secondary/protocol endpoint

Time to Death From Any Cause

Time frame:From randomization up to 4.2 years

time to event, event

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Time to New-Onset T2DM

Time frame:From randomization up to 4.2 years

time to event, event

Secondary/protocol endpoint/low confidence

Change From Baseline in Double Product

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

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Mean Arterial Pressure

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

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.