A Clinical Study Testing Enicepatide in Participants Living With Overweight or Obesity and Cardiovascular Disease (Enith-MACE)
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).
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
Tutki yhteystietojen varmuuskopiointi
- Nimi: Reference Study ID Number: WC46385 https://forpatients.roche.com/ No attachments to email below
- Puhelinnumero: 888-662-6728 (U.S. Only)
- Sähköposti: global-roche-genentech-trials@gene.com
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
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Placebo Comparator: Arm 1: Placebo
Participants will receive volume-matched placebo. |
Participants will receive volume-matched placebo as per the schedule described in the protocol. |
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Kokeellinen: Arm 2: Enicepatide
Participants will receive enicepatide. |
Participants will receive enicepatide as per the schedule described in the protocol.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Time to First Occurrence of Any Component of 5-point (5P) MACE
Aikaikkuna: From randomization up to 4.2 years
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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
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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Time to First Occurrence of Any Component of 3-point (3P) MACE
Aikaikkuna: 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
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Time to New-Onset T2DM
Aikaikkuna: From randomization up to 4.2 years
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From randomization up to 4.2 years
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Total Occurrence of All-Cause Hospitalization
Aikaikkuna: From randomization up to 4.2 years
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From randomization up to 4.2 years
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Time to Death From Any Cause
Aikaikkuna: From randomization up to 4.2 years
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From randomization up to 4.2 years
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Time to CV Death
Aikaikkuna: From randomization up to 4.2 years
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From randomization up to 4.2 years
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Incidence and Severity of Adverse Events
Aikaikkuna: From baseline up to 4.2 years
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From baseline up to 4.2 years
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Time to First Occurrence of Any Component of 4-point (4P) MACE
Aikaikkuna: 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
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Time to First Occurrence of HHF, Urgent HF Visit, or CV Death
Aikaikkuna: From randomization up to 4.2 years
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From randomization up to 4.2 years
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Time to First Occurrence of HHF, Urgent HF Visit, or All-Cause Mortality
Aikaikkuna: From randomization up to 4.2 years
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From randomization up to 4.2 years
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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
Aikaikkuna: From baseline through Week 48
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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
Aikaikkuna: From baseline through Week 48
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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
Aikaikkuna: From baseline through Week 48
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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
Aikaikkuna: From baseline through Week 48
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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
Aikaikkuna: From baseline through Week 48
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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
Aikaikkuna: From baseline through Week 48
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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
Aikaikkuna: From baseline through Week 48
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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
Aikaikkuna: From baseline through Week 48
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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
Aikaikkuna: From baseline through Week 48
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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
Aikaikkuna: From baseline through Week 48
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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
Aikaikkuna: From baseline through Week 48
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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
Aikaikkuna: From randomization up to 4.2 years
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From randomization up to 4.2 years
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Change From Baseline in Body Weight
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Waist Circumference
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Waist-to-Height Ratio
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Systolic Blood Pressure
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Diastolic Blood Pressure
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Heart Rate
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Double Product
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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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
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Mean Arterial Pressure
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Total Cholesterol
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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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)
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Low-Density Lipoprotein (LDL)
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in HDL
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Triglycerides (TG)
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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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)
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Change From Baseline in Hemoglobin A1c (HbA1c)
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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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)
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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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)
Aikaikkuna: From baseline through the end of study (up to 4.2 years)
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From baseline through the end of study (up to 4.2 years)
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Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Yhteistyökumppanit
Yhteistyökumppanit
Tutkijat
Tutkijat
- Opintojohtaja: Clinical Trials, Hoffmann-La Roche
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- WC46385
- 2026-526958-14-00 (Ctis)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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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