OverweightPhase 3Enith-MACENCT07918846
A Clinical Study Testing Enicepatide in Participants Living With Overweight or Obesity and Cardiovascular Disease
A Phase 3 study testing Enicepatide in people with Overweight and Obesity, run by Hoffmann-La Roche.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity, Cardiovascular Disease
- What is being tested?
- Enicepatide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,200 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2027to 17 Apr 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: WC46385 https://forpatients.roche.com/ No attachments to email below contact
Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry contact
About this study
Official title: 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
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).
- Conditions
- Overweight, Obesity, Cardiovascular Disease
- Being tested
- Enicepatide, Placebo
- Medical subject headings
- Overweight, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnicepatideCombination product
Also called RO7795068, CT-388, RG6640
Participants will receive enicepatide as per the schedule described in the protocol.
PlaceboCombination product
Participants will receive volume-matched placebo as per the schedule described in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Placebo | Placebo comparator | Participants will receive volume-matched placebo. Receives: Combination Product: Placebo |
| Arm 2: Enicepatide | Experimental | Participants will receive enicepatide. Receives: Combination Product: Enicepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization up to 4.2 years
Secondary outcomes (39)
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.
Measured: From randomization up to 4.2 years
Time to New-Onset T2DM
Measured: From randomization up to 4.2 years
Total Occurrence of All-Cause Hospitalization
Measured: From randomization up to 4.2 years
Time to Death From Any Cause
Measured: From randomization up to 4.2 years
Time to CV Death
Measured: From randomization up to 4.2 years
Incidence and Severity of Adverse Events
Measured: From baseline up to 4.2 years
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.
Measured: From randomization up to 4.2 years
Time to First Occurrence of HHF, Urgent HF Visit, or CV Death
Measured: From randomization up to 4.2 years
Time to First Occurrence of HHF, Urgent HF Visit, or All-Cause Mortality
Measured: From randomization up to 4.2 years
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
Measured: From baseline through Week 48
Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Role-Physical Domain Score
Measured: From baseline through Week 48
Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Bodily Pain Domain Score
Measured: From baseline through Week 48
Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form General Health Domain Score
Measured: From baseline through Week 48
Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Vitality Domain Score
Measured: From baseline through Week 48
Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Social Functioning Domain Score
Measured: From baseline through Week 48
Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Role-Emotional Domain Score
Measured: From baseline through Week 48
Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Mental Health Domain Score
Measured: From baseline through Week 48
Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Physical Component Summary Score
Measured: From baseline through Week 48
Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Mental Component Summary Score
Measured: From baseline through Week 48
Change From Baseline in Health Status as Assessed by the EuroQol-5 Dimensions 5-Level (EQ-5D-5L) Score
Measured: From baseline through Week 48
Time To First Occurrence of Sustained ≥40% Estimated Glomerular Filtration Rate (eGFR) Decline From Baseline, End Stage Kidney Disease (ESKD), or Renal Death
Measured: From randomization up to 4.2 years
Change From Baseline in Body Weight
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Waist Circumference
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Waist-to-Height Ratio
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Systolic Blood Pressure
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Diastolic Blood Pressure
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Heart Rate
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Double Product
Double product is defined as heart rate multiplied by systolic blood pressure.
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Pulse Pressure
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Mean Arterial Pressure
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Total Cholesterol
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Non-High-Density Lipoprotein (HDL)
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Low-Density Lipoprotein (LDL)
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in HDL
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Triglycerides (TG)
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Very-low-Density Lipoprotein (vLDL)
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Hemoglobin A1c (HbA1c)
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Measured: From baseline through the end of study (up to 4.2 years)
Change From Baseline in N-Terminal pro-B-Type Natriuretic Peptide (NT-proBNP)
Measured: From baseline through the end of study (up to 4.2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start6 Jan 2027 (estimated)
- Primary completion20 Mar 2031 (estimated)
- Study completion17 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918846
- Sponsor's protocol ID
- WC46385
- Other IDs
- 2026-526958-14-00
- Acronym
- Enith-MACE
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07918846
- Acronym / sponsor ID
- Enith-MACE / WC46385
- Conditions
- Overweight, Obesity, Cardiovascular Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8,200 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Study start
- 6 Jan 2027 (estimated)
- Primary completion
- 20 Mar 2031 (estimated)
- Study completion
- 17 Apr 2031 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Placebo | Placebo comparator | Combination Product: PlaceboParticipants will receive volume-matched placebo. |
| Arm 2: Enicepatide | Experimental | Combination Product: EnicepatideParticipants will receive enicepatide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnicepatideAlso: RO7795068, CT-388, RG6640Participants will receive enicepatide as per the schedule described in the protocol. | Combination product | Arm 2: Enicepatide |
| PlaceboParticipants will receive volume-matched placebo as per the schedule described in the protocol. | Combination product | Arm 1: Placebo |
Primary outcome
Time to First Occurrence of Any Component of 5-point (5P) MACE
Time frame: From randomization up to 4.2 years
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.
39 secondary outcomes
Time to First Occurrence of Any Component of 3-point (3P) MACE
Time frame: From randomization up to 4.2 years
Time to New-Onset T2DM
Time frame: From randomization up to 4.2 years
Total Occurrence of All-Cause Hospitalization
Time frame: From randomization up to 4.2 years
Time to Death From Any Cause
Time frame: From randomization up to 4.2 years
Time to CV Death
Time frame: From randomization up to 4.2 years
Incidence and Severity of Adverse Events
Time frame: From baseline up to 4.2 years
Time to First Occurrence of Any Component of 4-point (4P) MACE
Time frame: From randomization up to 4.2 years
Time to First Occurrence of HHF, Urgent HF Visit, or CV Death
Time frame: From randomization up to 4.2 years
Time to First Occurrence of HHF, Urgent HF Visit, or All-Cause Mortality
Time frame: From randomization up to 4.2 years
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 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 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 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 in HRQoL as Assessed by the SF-36 V2 Acute Form Vitality Domain Score
Time frame: From baseline through Week 48
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 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 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 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 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 in Health Status as Assessed by the EuroQol-5 Dimensions 5-Level (EQ-5D-5L) Score
Time frame: From baseline through Week 48
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
Change From Baseline in Body Weight
Time frame: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Waist Circumference
Time frame: From baseline through the end of study (up to 4.2 years)
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 in Systolic Blood Pressure
Time frame: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Diastolic Blood Pressure
Time frame: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Heart Rate
Time frame: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Double Product
Time frame: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Pulse Pressure
Time frame: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Mean Arterial Pressure
Time frame: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Total Cholesterol
Time frame: From baseline through the end of study (up to 4.2 years)
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 in Low-Density Lipoprotein (LDL)
Time frame: From baseline through the end of study (up to 4.2 years)
Change From Baseline in HDL
Time frame: From baseline through the end of study (up to 4.2 years)
Change From Baseline in Triglycerides (TG)
Time frame: From baseline through the end of study (up to 4.2 years)
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 in Hemoglobin A1c (HbA1c)
Time frame: From baseline through the end of study (up to 4.2 years)
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 in N-Terminal pro-B-Type Natriuretic Peptide (NT-proBNP)
Time frame: From baseline through the end of study (up to 4.2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: WC46385 https://forpatients.roche.com/ No attachments to email below contact
Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enicepatide in people with Overweight and Obesity, run by Hoffmann-La Roche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: WC46385 https://forpatients.roche.com/ No attachments to email below (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Occurrence of Any Component of 5-point (5P) MACE (time frame: From randomization up to 4.2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.