Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Identify the Expanded Access Program, if Any. This is Required Unless the Expanded Access Type is "Individual Patients." A Randomized, Parallel, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of JMT206 Injection Alone or in Combination With Semaglutide in Obese Participants
Use these resources to provide understandable information about this study to patients, families, and health care providers:
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Clinical Trials Information Group officer
- 전화번호: 86-0311-69085587
- 이메일: ctr-contact@mail.ecspc.com
연구 장소
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Beijing, 중국
- 모병
- Peking University People's Hospital
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연락하다:
- Linong Ji
- 전화번호: +86 13910978815
- 이메일: jiln@bjmu.edu.cn
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18~65 (including threshold values), male or female participants;
- BMI ≥ 30 kg/m²;
- Weight change <5% within the 3 months prior to screening
- Voluntarily sign the informed consent form before the trial..
Exclusion Criteria:
1) Those known to have a history of allergy to any component or related preparations in the investigational drug and its excipients, or have severe allergic diseases or allergic constitution; 2) Participants with a history of diabetes mellitus or hypoglycemic episodes; 3) Obesity is related to medication or diseases; Or weight gain caused by non-fat content; or monogene mutationsobesity; 4) History of weight loss surgery and/or treatment within the past year; 5) History of severe gastrointestinal disease or gastrointestinal surgery, clinically significant gastric emptying abnormalities, or long-term use of medications directly affecting gastrointestinal motility; 6) Having comorbidities known to affect skeletal muscle proteins; 7) A history of acute or chronic pancreatitis; 8) Acute gallbladder disease within one year prior to screening; 9) Previous or family history of medullary thyroid carcinoma or type 2 endocrine adenomatosis; 10) Severe cardiovascular or cerebrovascular events within 6 months prior to screening; 11) Any type of treated or untreated malignant tumor within 5 years prior to screening; 12) History of severe mental illness; 13) Use of drugs or products that may cause weight changes within 3 months prior to screening; 14) Use of drugs or products affecting skeletal muscle synthesis within 3 months prior to screening; 15) Participants deemed otherwise unsuitable for this trial by the investigator.
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: JMT206 injection group 2
JMT206 injection dose 2 administered subcutaneously (SC) once a week |
JMT206 injection administered subcutaneously (SC) once a week |
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실험적: JMT206 injection group 3
JMT206 injection dose 3 administered subcutaneously (SC) once a week |
JMT206 injection administered subcutaneously (SC) once a week |
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실험적: JMT206 injection + Semaglutide group 1
JMT206 injection dose 1 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
JMT206 injection administered subcutaneously (SC) once a week Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
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실험적: JMT206 injection + Semaglutide group 2
JMT206 injection dose 2 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
JMT206 injection administered subcutaneously (SC) once a week Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
|
실험적: JMT206 injection + Semaglutide group 3
JMT206 injection dose 3 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased |
JMT206 injection administered subcutaneously (SC) once a week Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
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위약 비교기: Placebo
Placebo administered subcutaneously (SC) once a week |
Placebo administered subcutaneously (SC) once a week. |
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위약 비교기: Placebo+ Semaglutide
Placebo administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. |
Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased. Placebo administered subcutaneously (SC) once a week. |
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실험적: JMT206 injection group 1
JMT206 injection dose 1 administered subcutaneously (SC) once a week |
JMT206 injection administered subcutaneously (SC) once a week |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Incidence of Adverse Events (AE) assessed by CTCAE v6.0
기간: Baseline through week 19
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Baseline through week 19
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- JMT206-003
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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