A Clinical Study Testing Enicepatide in Participants Living With Overweight or Obesity and Cardiovascular Disease (Enith-MACE)
2. november 2026 oppdatert av: Hoffmann-La Roche
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).
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
8200
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
Studer Kontakt Backup
- Navn: Reference Study ID Number: WC46385 https://forpatients.roche.com/ No attachments to email below
- Telefonnummer: 888-662-6728 (U.S. Only)
- E-post: global-roche-genentech-trials@gene.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Arm 1: Placebo
Participants will receive volume-matched placebo. |
Participants will receive volume-matched placebo as per the schedule described in the protocol. |
|
Eksperimentell: Arm 2: Enicepatide
Participants will receive enicepatide. |
Participants will receive enicepatide as per the schedule described in the protocol.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to First Occurrence of Any Component of 5-point (5P) MACE
Tidsramme: 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. |
From randomization up to 4.2 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to First Occurrence of Any Component of 3-point (3P) MACE
Tidsramme: From randomization up to 4.2 years
|
The components of this composite 3P MACE endpoint consist of CV death, non-fatal MI or non-fatal stroke. |
From randomization up to 4.2 years
|
|
Time to New-Onset T2DM
Tidsramme: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
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Total Occurrence of All-Cause Hospitalization
Tidsramme: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
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Time to Death From Any Cause
Tidsramme: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
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Time to CV Death
Tidsramme: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
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Incidence and Severity of Adverse Events
Tidsramme: From baseline up to 4.2 years
|
From baseline up to 4.2 years
|
|
|
Time to First Occurrence of Any Component of 4-point (4P) MACE
Tidsramme: From randomization up to 4.2 years
|
The components of this composite 4P MACE endpoint consist of CV death, non-fatal MI, non-fatal stroke, or HHF or urgent HF visit. |
From randomization up to 4.2 years
|
|
Time to First Occurrence of HHF, Urgent HF Visit, or CV Death
Tidsramme: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
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Time to First Occurrence of HHF, Urgent HF Visit, or All-Cause Mortality
Tidsramme: From randomization up to 4.2 years
|
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
Tidsramme: From baseline through Week 48
|
From baseline through Week 48
|
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Role-Physical Domain Score
Tidsramme: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Bodily Pain Domain Score
Tidsramme: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form General Health Domain Score
Tidsramme: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Vitality Domain Score
Tidsramme: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Social Functioning Domain Score
Tidsramme: From baseline through Week 48
|
From baseline through Week 48
|
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Role-Emotional Domain Score
Tidsramme: From baseline through Week 48
|
From baseline through Week 48
|
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Mental Health Domain Score
Tidsramme: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Physical Component Summary Score
Tidsramme: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Mental Component Summary Score
Tidsramme: From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in Health Status as Assessed by the EuroQol-5 Dimensions 5-Level (EQ-5D-5L) Score
Tidsramme: From baseline through Week 48
|
From baseline through Week 48
|
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Time To First Occurrence of Sustained ≥40% Estimated Glomerular Filtration Rate (eGFR) Decline From Baseline, End Stage Kidney Disease (ESKD), or Renal Death
Tidsramme: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
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Change From Baseline in Body Weight
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Waist Circumference
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Waist-to-Height Ratio
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Systolic Blood Pressure
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Diastolic Blood Pressure
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Heart Rate
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Double Product
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
Double product is defined as heart rate multiplied by systolic blood pressure. |
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Pulse Pressure
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Mean Arterial Pressure
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Total Cholesterol
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Non-High-Density Lipoprotein (HDL)
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Low-Density Lipoprotein (LDL)
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in HDL
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Triglycerides (TG)
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Very-low-Density Lipoprotein (vLDL)
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Hemoglobin A1c (HbA1c)
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in N-Terminal pro-B-Type Natriuretic Peptide (NT-proBNP)
Tidsramme: From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
6. januar 2027
Primær fullføring (Antatt)
20. mars 2031
Studiet fullført (Antatt)
17. april 2031
Datoer for studieregistrering
Først innsendt
2. november 2026
Først innsendt som oppfylte QC-kriteriene
2. november 2026
Først lagt ut (Faktiske)
5. november 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2026
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- WC46385
- 2026-526958-14-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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