Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH). MASH is more advanced stage of a broader liver disease, MASLD. MASLD is a liver condition caused by too much fat building up in the liver. This can lead to liver scarring and inflammation and can reduce the liver's ability to keep the body healthy. Cell death-inducing DFFA-like effector B (CIDEB) is a protein made by liver cells that helps the liver to store fat.
The study is looking at:
- What side effects ALN-CIDEB might cause
- How well ALN-CIDEB works to change liver fat, liver injury, and liver scarring
- How ALN-CIDEB could affect the body and the liver, which can help researchers understand why ALN-CIDEB works better for some people than others
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Clinical Trials Administrator
- 전화번호: 844-734-6643
- 이메일: clinicaltrials@regeneron.com
연구 장소
-
-
Texas
-
Georgetown, Texas, 미국, 78628
- 모병
- Advanced Medical Trials
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
- Has a clinical diagnosis of MASLD, as defined in the protocol
- Has a liver stiffness measurement between 6 and 20 kilopascals (kPa), as measured by a FibroScan® scan during screening or within approximately 3 months of screening, as defined in the protocol
Key Exclusion Criteria:
- Has a known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol
- Has prior or current suspected or known drug-induced liver injury within approximately 1 year prior to screening
- Has a history of liver transplantation, current placement on a liver transplant list, or Model for End-Stage Liver Disease (MELD) score >12
- Has a known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion
- Has prior, current, or planned future use (during the treatment period) of a GLP-1 receptor agonist-based therapy or any medication approved for the treatment of MASH (eg, resmetirom) unless used at a generally stable dose and regimen since at least 3 months prior to screening visit and throughout the screening period with no change to the dose or regimen anticipated during the treatment period, as defined in the protocol
- Has evidence of uncontrolled human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection during screening, as defined in the protocol
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 위약
|
Administered per the protocol |
|
실험적: ALN-CIDEB Dose Level 1
|
Administered per the protocol |
|
실험적: ALN-CIDEB Dose Level 2
|
Administered per the protocol |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
기간: Through Week 64
|
Through Week 64
|
|
Severity of TEAEs
기간: Through Week 64
|
Through Week 64
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP)
기간: At Week 52
|
At Week 52
|
|
Change from Baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)
기간: At Week 52
|
At Week 52
|
|
Change from Baseline in Aspartate Aminotransferase (AST)
기간: Through Week 64
|
Through Week 64
|
|
Change from Baseline in Alanine Aminotransferase (ALT)
기간: Through Week 64
|
Through Week 64
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Clinical Trial Management, Regeneron Pharmaceuticals
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ALN-CIDEB-MASLD-2604
- 2026-526723-22-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD 공유 기간
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD 공유 액세스 기준
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .