A Clinical Study Testing Enicepatide in Participants Living With Overweight or Obesity and Cardiovascular Disease (Enith-MACE)
2 november 2026 uppdaterad 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).
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
8200
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
Studera Kontakt Backup
- Namn: 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
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: Arm 1: Placebo
Participants will receive volume-matched placebo. |
Participants will receive volume-matched placebo as per the schedule described in the protocol. |
|
Experimentell: Arm 2: Enicepatide
Participants will receive enicepatide. |
Participants will receive enicepatide as per the schedule described in the protocol.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to First Occurrence of Any Component of 5-point (5P) MACE
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to First Occurrence of Any Component of 3-point (3P) MACE
Tidsram: 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
Tidsram: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
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Total Occurrence of All-Cause Hospitalization
Tidsram: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
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Time to Death From Any Cause
Tidsram: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
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Time to CV Death
Tidsram: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
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Incidence and Severity of Adverse Events
Tidsram: From baseline up to 4.2 years
|
From baseline up to 4.2 years
|
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Time to First Occurrence of Any Component of 4-point (4P) MACE
Tidsram: 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
Tidsram: 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
Tidsram: From randomization up to 4.2 years
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
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Change From Baseline in Body Weight
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Clinical Trials, Hoffmann-La Roche
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
6 januari 2027
Primärt slutförande (Beräknad)
20 mars 2031
Avslutad studie (Beräknad)
17 april 2031
Studieregistreringsdatum
Först inskickad
2 november 2026
Först inskickad som uppfyllde QC-kriterierna
2 november 2026
Första postat (Faktisk)
5 november 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 november 2026
Senast verifierad
1 oktober 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- WC46385
- 2026-526958-14-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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