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임상시험 NCT07220785은(는) 전신 지방이영양증에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy 3상 28 소아

대상자모집전
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임상시험 NCT07220785은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 전신 지방이영양증에 대해 진행되며, 3상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2026년 2월 27일부터 가능하며, 28명의 참여자를 모집할 예정입니다. 리제네론 파마슈티컬스이(가) 진행하는 이 연구는 2028년 9월 8일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 5일에 갱신되었습니다.
간단한 개요
This study is researching a new drug called mibavademab (called "study drug"). The study involves participants with a condition called Generalized Lipodystrophy (GLD). The aim of the study is to see how well mibavademab works and what side effects it has. Researchers will also look at how much mibavademab is in the body at different times.

This is a 2-part study: Part A is an efficacy study in pediatric and adult pa...

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공식 제목

A Two-Part, Randomized, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Mibavademab in Patients With Generalized Lipodystrophy

질환명
전신 지방이영양증
기타 연구 식별자
  • R4461-GLD-2285
  • 2024-519879-25-00 (등록 식별자) (EUCT Number)
NCT 번호
실제 연구 시작일
2026-02-27
최신 업데이트 게시
2026-02-05
예상 연구 완료일
2028-09-08
계획된 등록 인원
28
연구종류
중재연구
단계/상
3상
상태
대상자모집전
키워드
Subcutaneous (SC) adipose tissue
GLD
Berardinelli-Seip Syndrome
Congenital Generalized Lipodystrophy
CGL
Lawrence Syndrome
Acquired Generalized Lipodystrophy
AGL
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
사중맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Part A: Arm A
Mibavademab
Administered as per the protocol
실험적Part A: Arm B
Mibavademab
Administered as per the protocol
위약
Administered as per the protocol
실험적Part A: Arm C
Mibavademab
Administered as per the protocol
위약 대조군Part A: Arm D
위약
Administered as per the protocol
실험적Part B
Mibavademab
Administered as per the protocol
주요결과변수
결과변수측정값 설명시간 범위
Change in Hemoglobin A1c (HbA1c)
Part A
Through 36 weeks of exposure to mibavademab
Percent change in fasting Triglycerides (TG)
Part A
Through 36 weeks of exposure to mibavademab
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Part B
Up to 15 months
Severity of TEAEs
Part B
Up to 15 months
Concentrations of total mibavademab in serum
Part B
Up to 15 months
이차결과변수
결과변수측정값 설명시간 범위
Change in HbA1c compared to placebo
Part A
From baseline to week 20
Change in HbA1c compared to placebo
Part A
From week 56 to week 64
Change in HbA1c
Part B
From baseline to week 52
Percent change in fasting TG compared to placebo
Part A
From baseline to week 20
Percent change in fasting TG compared to placebo
Part A
From week 56 to week 64
Percent change in fasting TG
Part B
From baseline to week 52
Occurrence of HbA1c <7%
Part A
At week 20
Occurrence of HbA1c <7%
Part A
Through 36 weeks of exposure to mibavademab
Occurrence of HbA1c <6.5%
Part A
At week 20
Occurrence of HbA1c <6.5%
Part A
Through 36 weeks of exposure to mibavademab
Occurrence of fasting TG <500 mg/dL
Part A
At week 20
Occurrence of fasting TG <500 mg/dL
Part A
Through 36 weeks of exposure to mibavademab
Occurrence of fasting TG <200 mg/dL
Part A
At week 20
Occurrence of fasting TG <200 mg/dL
Part A
Through 36 weeks of exposure to mibavademab
Occurrence of fasting TG <150 mg/dL
Part A
At week 20
Occurrence of fasting TG <150 mg/dL
Part A
Through 36 weeks of exposure to mibavademab
Percent change in Liver Fat Content (LFC)
Part A
From baseline to week 20
Percent change in Liver Fat Content (LFC)
Part A
From pre-mibavademab exposure to week 56
Change in liver volume
Part A
From baseline to week 20
Change in liver volume
Part A
From pre-mibavademab exposure to week 56
Change in fasting glucose
Part A
From baseline to week 20
Change in fasting glucose
Part A
Through 36 weeks of exposure to mibavademab
Change in fasting glucose
Part A
From week 56 to week 64
Change in total daily insulin dose
Part A
From baseline to week 20
Change in total daily insulin dose
Part A
Through 36 weeks of exposure to mibavademab
Change in total daily insulin dose
Part A
From week 56 to week 64
Change in total daily insulin dose
Part B
From baseline to week 52
Concentrations of total mibavademab in serum
Part A
Through Week 72
Occurrence of anti-drug antibodies (ADA) to mibavademab
Part A
Through Week 72
Occurrence of ADA to mibavademab
Part B
Through Week 60
Titer of ADA to mibavademab
Part A
Through Week 72
Titer of ADA to mibavademab
Part B
Through Week 60
Occurrence of TEAEs
Part A
Through Week 72
Severity of TEAEs
Part A
Through Week 72
참여 도우미
적격성 기준

연령대
어린이, 성인, 노인
최소 연령
2 Years
참여 가능한 성별
전체

1. Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines

For Part A only:

  1. Participants ≥2 years of age at screening

  2. At least one of the below criteria are fulfilled during screening (measurements can be repeated once during screening period)

    • HbA1c ≥7%
    • Fasting TG ≥500 mg/dL
    • Fasting TG value of ≥300 mg/dL and the presence of another complication of GLD consistent with leptin deficiency (history of diabetes mellitus, hyperphagia, Metabolic Associated Fatty Liver Disease (MAFLD), polycystic ovary syndrome, etc)
  3. Weight ≥15 kg at screening

  4. Willing and able to provide, or have the treating physician provide, values of HbA1c and fasting TG from at least 6 months prior to screening, as described in the protocol

For Part B only:

  1. Participants ≥2 and <12 years of age at screening
  2. No metabolic criteria or minimum weight for study entry is required

  1. Has a current diagnosis of familial or acquired partial lipodystrophy or autoimmune (Type 1) diabetes mellitus
  2. Any malignancy, eg, lymphoma, within the past 1 year, prior to screening visit, as described in the protocol
  3. eGFR of <30 mL/min/1.73 m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine or Schwartz equation, as applicable, at screening. Assessment can be repeated once
  4. History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, clinically significant arrhythmia, as described in the protocol
  5. Treatment with over-the-counter or prescription medications with the intention of weight loss within 3 months prior to the screening visit

For Part A only:

  1. Treatment with metreleptin within 3 months of the screening visit
  2. Addition or discontinuation of prescription medications or over-the-counter supplements for diabetes and/or dyslipidemia within 3 months prior to the start of the screening period, or changes in the use of these medications, as described in the protocol
  3. Significant changes to lifestyle and diet, as described in the protocol
  4. Current chronic treatment with high-dose corticosteroids, defined as use of higher than physiologic doses, as described in the protocol

NOTE: Other protocol defined inclusion/exclusion criteria apply.

Regeneron Pharmaceuticals logo리제네론 파마슈티컬스
연구 대표 연락처
연락처: Clinical Trials Administrator, 844-734-6643, [email protected]
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