A Clinical Study Testing Enicepatide in Participants Living With Overweight or Obesity and Cardiovascular Disease (Enith-MACE)
2026년 11월 2일 업데이트: 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).
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
8200
단계
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
연구 연락처 백업
- 이름: Reference Study ID Number: WC46385 https://forpatients.roche.com/ No attachments to email below
- 전화번호: 888-662-6728 (U.S. Only)
- 이메일: global-roche-genentech-trials@gene.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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위약 비교기: 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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실험적: Arm 2: Enicepatide
Participants will receive enicepatide. |
Participants will receive enicepatide as per the schedule described in the protocol.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to First Occurrence of Any Component of 5-point (5P) MACE
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to First Occurrence of Any Component of 3-point (3P) MACE
기간: 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
기간: 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
기간: 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
기간: From randomization up to 4.2 years
|
From randomization up to 4.2 years
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Time to CV Death
기간: From randomization up to 4.2 years
|
From randomization up to 4.2 years
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Incidence and Severity of Adverse Events
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 연구 책임자: Clinical Trials, Hoffmann-La Roche
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2027년 1월 6일
기본 완료 (추정된)
기본 완료
2031년 3월 20일
연구 완료 (추정된)
연구 완료
2031년 4월 17일
연구 등록 날짜
최초 제출
최초 제출
2026년 11월 2일
QC 기준을 충족하는 최초 제출
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처음 게시됨 (실제)
처음 게시됨
2026년 11월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 11월 5일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 11월 2일
마지막으로 확인됨
마지막으로 확인됨
2026년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- WC46385
- 2026-526958-14-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .