- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07921316
Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations After Multiple Doses
A Phase 1, Open-label, Randomized, Parallel Group, Multiple Dose Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations in Participants Living With Overweight or Obesity
The main objective of this study is to compare the pharmacokinetics of maridebart cafraglutide administered as a single dose using two different subcutaneous (SC) presentations in participants with overweight or obesity after they have received escalating doses of the study drug.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Amgen Call Center
- 전화번호: 866-572-6436
- 이메일: medinfo@amgen.com
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults 18 to 60 years of age.
- Body mass index (BMI) between 25 and 35 kilograms per square meter (kg/m^2), inclusive.
- Stable body weight, with less than 5 kilograms (kg) (11 pounds) of weight change in the past 3 months.
- No significant changes in diet or eating habits in the past 3 months.
- Generally healthy. People with certain well-controlled medical conditions, such as sleep apnea, high blood pressure, high cholesterol, or underactive thyroid, may qualify if their treatment has been stable for at least 3 months and is approved by the study doctor.
- Willing to follow the study's birth control requirements, if applicable, during the study and for the study-defined period after the last dose of study drug.
- Able and willing to provide informed consent before participating in study procedures.
Exclusion Criteria:
- History of diabetes or current diabetes, except diabetes during pregnancy, or blood sugar levels that meet the study's definition of diabetes.
- Certain hormonal conditions that can cause weight gain, such as Cushing's syndrome.
- History of pancreatitis (inflammation of the pancreas) or certain abnormal pancreatic blood test results.
- History of cancer within the past 5 years, except certain early-stage cancers or nonmelanoma skin cancers.
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2).
- Uncontrolled thyroid disease or certain abnormal thyroid blood test results.
- Significant stomach or intestinal conditions, including delayed stomach emptying, ulcers, or inflammatory bowel disease, or a history of certain digestive system surgeries.
- Weight-loss surgery within the past 6 months.
- Significant heart disease, abnormal heart rhythms, or blood pressure or heart rate outside the study's allowed limits.
- Significant kidney or liver problems, or certain abnormal kidney or liver blood test results.
- Positive tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, with certain exceptions for past hepatitis B vaccination or infection.
- History of certain serious or unstable mental health conditions, self-injury within the past 5 years, or any previous suicide attempt.
- History of ischemic optic neuropathy, a condition involving damage to the optic nerve caused by reduced blood flow.
- Allergy or intolerance to maridebart cafraglutide (AMG 133), similar medications, or their ingredients.
- Use of certain medications, including weight-loss or diabetes medications that act on glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP), within the restricted time periods before the study.
- Use of certain herbal products, vitamins, or supplements within 30 days before enrollment, unless approved by the study doctor.
- Recent participation in another investigational drug study or previous participation in a study of maridebart cafraglutide.
- History of alcohol or drug abuse, recent illegal drug use, or positive alcohol or drug screening results not explained by permitted prescription medications.
- Pregnant, breastfeeding, or planning to breastfeed during the study or within the study-defined period after the last dose of study drug.
- Recent blood, plasma, or platelet donation within the study's restricted time periods.
- Recent strenuous exercise or unwillingness to follow study restrictions on physical activity, alcohol, recreational drugs, diet, or other activities.
- Difficulty providing blood samples because of poor vein access.
- Any other medical condition, abnormal test result, or circumstance that the study doctor believes could make participation unsafe or interfere with study procedures.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Maridebart Cafraglutide: SC Presentation 1
Participants will receive maridebart cafraglutide administered subcutaneously (SC) during the initial dose-escalation period and, after randomization, will continue to receive maridebart cafraglutide SC administered using SC Presentation 1. |
Administered subcutaneously.
다른 이름들:
|
|
실험적: Maridebart Cafraglutide: SC Presentation 2
Participants will receive maridebart cafraglutide administered SC during the initial dose-escalation period and, after randomization, will continue to receive maridebart cafraglutide SC administered using SC Presentation 2. |
Administered subcutaneously.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Area Under the Plasma Concentration-time Curve from Time 0 to 28 days post dose (AUC 0-28) of Maridebart Cafraglutide
기간: Up to 113 days
|
Up to 113 days
|
|
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
기간: Up to 113 days
|
Up to 113 days
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
기간: TEAEs: From baseline (Day 1) up to end of trial (approximately 28 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 32 weeks)
|
TEAEs: From baseline (Day 1) up to end of trial (approximately 28 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 32 weeks)
|
|
Number of Participants Who Develop Anti-Maridebart Cafraglutide Antibodies
기간: Baseline (Day 1) up to end of trial (approximately 28 weeks)
|
Baseline (Day 1) up to end of trial (approximately 28 weeks)
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: MD, Amgen
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20260175
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD 공유 기간
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD 공유 액세스 기준
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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