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A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes

2026년 9월 8일 업데이트: Hoffmann-La Roche

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

300

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

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: YC46401 https://forpatients.roche.com No attachments to email below.
  • 전화번호: 888-662-6728 (U.S. Only)
  • 이메일: global-roche-genentech-trials@gene.com

연구 장소

  • 중국
      • Beijing, 중국, 100044
        • 모병
        • Peking University People's Hospital
      • Changchun, 중국, 130041
        • 모병
        • The Second Hospital of Jilin University
      • Hefei, 중국, 230601
        • 모병
        • The Second Affiliated Hospital of Anhui Medical University
      • Herbin, 중국, 150001
        • 모병
        • The Fourth Affiliated Hospital of Harbin Medical University
      • Huai'an, 중국
        • 모병
        • Huai'an first people's hospital
      • Huzhou, 중국, 313000
        • 모병
        • Huzhou Central Hospital
      • Jinan, 중국, 250013
        • 모병
        • Jinan Central Hospital
      • Langfang, 중국, 065000
        • 모병
        • Hebei Petro China Central Hospital
      • Luoyang, 중국, 471000
        • 모병
        • Luoyang Third People's Hospital
      • Nanjing, 중국, 211100
        • 모병
        • The Affiliated Jiangning Hospital of Nanjing Medical University
      • Shanghai, 중국, 200120
        • 모병
        • Shanghai East Hospital
      • Shanghai, 중국, 200072
        • 모병
        • Shanghai Tenth People's Hospital
      • Shanghai, 중국, 201304
        • 모병
        • Shanghai Fifth People's Hospital affiliated to Fudan University
      • Shanghai, 중국, 200336
        • 모병
        • Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shenyang, 중국, 110074
        • 모병
        • Shenyang Fifth People Hospital
      • Shenyang, 중국, 110016
        • 모병
        • The People's Hospital of Liaoning Province
      • Shijiazhuang, 중국, 050004
        • 모병
        • Hebei Medical University - The Second Hospital
      • Zibo, 중국, 255400
        • 모병
        • Zibo Municipal Hospital.
    • Henan
      • Zhengzhou, Henan, 중국, 450014
        • 모병
        • The Second Affiliated Hospital of Zhengzhou University
    • Shaanxi
      • Xianyang, Shaanxi, 중국, 712000
        • 모병
        • Yan'an University Xianyang Hospital
    • Zhejiang
      • Ningbo, Zhejiang, 중국, 315010
        • 모병
        • The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m^2) for participants with type 2 diabetes mellitus (T2DM)
  • BMI ≥28.0 kg/m^2 or BMI ≥24.0 and <28.0 kg/m^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM
  • Agreement to adhere to the contraception requirements

Exclusion Criteria:

  • History of Type 1 diabetes mellitus (T1DM)
  • Obesity induced by other endocrinologic disorders
  • Any planned major medical procedure or surgery during the study
  • History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
  • Any lifetime history of suicide attempt
  • History of any hematologic conditions that may interfere with HbA1c measurement
  • History of acute or chronic pancreatitis or clinically significant gallbladder disease
  • Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization
  • Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer
  • Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1/GIP RAs

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

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
참가자는 일치하는 위약을 받게 됩니다.
조합 제품: Placebo
Participants will receive matching placebo via SC injection as per the schedule in the protocol.
실험적: Enicepatide Dose 1
Participants will receive enicepatide Dose 1.
조합 제품: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
다른 이름들:
  • RO7795068
  • RG6640
  • CT-388
실험적: Enicepatide Dose 2
Participants will receive enicepatide Dose 2.
조합 제품: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
다른 이름들:
  • RO7795068
  • RG6640
  • CT-388
실험적: Enicepatide Dose 3
Participants will receive enicepatide Dose 3.
조합 제품: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
다른 이름들:
  • RO7795068
  • RG6640
  • CT-388

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Percent Change From Baseline in Body Weight at Week 52
기간: Baseline through Week 52
Baseline through Week 52

2차 결과 측정

결과 측정
기간
Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52
기간: At Week 52
At Week 52
Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52
기간: At Week 52
At Week 52
Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52
기간: At Week 52
At Week 52
Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3
기간: At Week 52
At Week 52
Change From Baseline in Body Weight at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Waist Circumference at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Fasting Glucose at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Fasting Insulin at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Triglyceride at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Systolic Blood Pressure at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in the Physical Functioning as Assessed by Short Form 36 Health Survey Acute, Version 2.0 (SF-36 v2 Acute) at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Physical Functioning Composite Score as Assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Body Weight at Week 52 in GLP-1 RA-based Treatment Naive Populations
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Waist-to-Hip Ratio at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Waist-to-Height Ratio at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Percentage of Participants With Prediabetes at Baseline Achieving Normoglycemia (Hemoglobin A1c [HbA1c] <5.7%) at Week 52
기간: At Week 52
At Week 52
Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Domain Scores and Component Summary Scores at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Questionnaire Domain Scores and Total Score at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Non-HDL Cholesterol at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Total Cholesterol at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Free Fatty Acids at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Diastolic Blood Pressure at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Serum Uric Acid at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Percentage of Participants Achieving ≥25% Body Weight Loss at Week 52, in Participants Receiving Enicepatide Dose 2 and Dose 3
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Body Mass Index (BMI) at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Body Weight by Obesity Class at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in HbA1c at Week 52 in Participants With T2DM
기간: Baseline through Week 52
Baseline through Week 52
Percentage of Participants With T2DM Achieving HbA1c of <5.7%, ≤6.5% and <7% at Week 52
기간: At Week 52
At Week 52
Change From Baseline in Total Lean Tissue Volume at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Total Lean Tissue Volume at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Total Adipose Tissue Volume at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Total Adipose Tissue Volume at Week 52
기간: Baseline through Week 52
Baseline through Week 52
Incidence and Severity of Adverse Events, With Severity Determined According to Mild, Moderate, and Severe Criteria
기간: Baseline to Safety Follow-Up (55 Weeks)
Baseline to Safety Follow-Up (55 Weeks)
Change From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score
기간: Baseline through Week 52
Baseline through Week 52
Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score
기간: Baseline through Week 52
Baseline through Week 52

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

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.

유용한 링크

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 (실제)

2026년 7월 3일

기본 완료 (추정된)

2028년 2월 24일

연구 완료 (추정된)

2028년 3월 15일

연구 등록 날짜

최초 제출

2026년 6월 22일

QC 기준을 충족하는 최초 제출

2026년 6월 22일

처음 게시됨 (실제)

2026년 6월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 8일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • YC46401

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

아니

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. .

구독하다