이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

주 1회 MET-097의 4가지 다른 요법의 안전성과 효능을 조사하기 위한 16주 2b상 연구 (VESPER-1)

2026년 8월 6일 업데이트: Pfizer

비만 및 과체중 참가자를 대상으로 주 1회 MET097의 4가지 서로 다른 요법에 대한 16주간의 안전성과 유효성을 조사하기 위한 제2b상, 다기관, 무작위, 위약 대조 이중 맹검 연구

이 연구는 활성 약물인 MET097이 위약과 비교하여 비만 또는 과체중 환자를 치료하는 데 얼마나 잘 작용하는지 테스트하기 위해 고안되었습니다. MET097 또는 위약은 16주 동안 매주 개인에게 제공됩니다. 개인이 MET097에 배정되면 네 가지 다른 복용량 수준 중 하나를 받게 됩니다.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

이는 비만 또는 과체중(체질량 지수[BMI)이 있는 성인 참가자의 체중 감소에 대한 MET097의 4가지 다른 용량 수준 대 위약의 효능 및 안전성을 조사하기 위한 다기관, 무작위, 이중 맹검, 위약 대조 연구입니다. ] 27~50kg/m2, 18~70세), 주 1회 16회 투여합니다. 모든 참가자는 안전을 위해 마지막 주간 용량 투여 후 11주(~5 반감기) 동안 추적 관찰됩니다.

연구 유형

중재적

등록 (실제)

239

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • California
      • Anaheim, California, 미국, 92801
        • Anaheim Clinical Trials, LLC
    • Florida
      • Hollywood, Florida, 미국, 92801
        • Research Centers of America

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

포함 기준:

  • 스크리닝 시 체질량 지수(BMI):

    • BMI ≥30kg/m2 및 ≤50.0kg/m2(아래 나열된 체중 관련 동반 질환이 있을 수 있음)

    • BMI ≥27.0kg/m2 ~ <30.0kg/m2(다음 체중 관련 동반 질환 중 하나 이상 포함):

      1. 고혈압: 혈압(BP)을 낮추는 약물을 복용 중이거나 스크리닝 당시 수축기 혈압 ≥130mmHg 또는 확장기 혈압 ≥80mmHg인 경우
      2. 이상지질혈증: 지질강하제를 복용 중이거나 저밀도지단백콜레스테롤(LDL-C) ≥160mg/dL(4.1mmol/L) 또는 중성지방 ≥150mg/dL(1.7mmol/L) 또는 고밀도지단백콜레스테롤(LDL-C) ≥150mg/dL(1.7mmol/L) 남성의 경우 콜레스테롤(HDL-C) <40mg/dL(1.0mmol/L) 또는 HDL-C <50mg/dL 스크리닝 시 여성의 경우 (1.3mmol/L)

스크리닝 전 3개월 이내에 안정적인 체중(증가 또는 감소 ≥5kg)

제외 기준:

  • 당뇨병(T1DM 또는 T2DM) 또는 당화혈색소 A1c(HbA1c) ≥ 6.5% 또는 공복 혈장 포도당 >125mg/dL로 진단됩니다.
  • 추정 사구체 여과율(eGFR) <75mL/분/1.73 m2
  • 췌장염의 역사
  • 갑상선수질암종(MTC) 또는 다발내분비샘종양증후군 2형(MEN-2)의 가족력 또는 개인력
  • 지난 2년 이내에 심각한 활동성 또는 불안정성 주요 우울 장애(MDD) 또는 기타 심각한 정신 장애의 병력
  • 평생 자살 시도 이력.

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: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
연구 기간 동안 멸균 0.9%(w/v) 식염수를 위약 치료제로 사용합니다.
의약품: 위약
연구 기간 동안 멸균 0.9%(w/v) 식염수를 위약 치료제로 사용합니다.
실험적: MET097 활성
MET097은 적정 없이 4가지 다른 용량 수준으로 주 1회 피하 투여됩니다. 연장 단계에는 매주보다 빈도가 낮은 투여 요법이 포함됩니다.
의약품: MET097
MET097은 인간 GLP-1의 초장기 작용, 완전 편향 아날로그입니다.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percent Change From Baseline in Body Weight at Week 28: Part A
기간: Baseline (last non-missing measurement prior to the first dose), Week 28
Analysis was performed using mixed model for repeated measures (MMRM) with treatment group, visit, and treatment by visit interaction, sex, and baseline body weight as fixed effects using unstructured covariance. The analysis excluded weight measurements after protocol specified intercurrent events (ICEs) including permanent treatment discontinuation, non-compliance to treatment and lifestyle change.
Baseline (last non-missing measurement prior to the first dose), Week 28

2차 결과 측정

결과 측정
측정값 설명
기간
Percent Change From Baseline in Body Weight at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169: Part A
기간: Baseline, Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169
Analysis was performed using MMRM with treatment group, visit, and treatment by visit interaction, sex, and baseline body weight as fixed effects using unstructured covariance excluding weight measurements after protocol specified intercurrent ICEs.
Baseline, Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169
Number of Participants With Reduction in Body Weight Greater Than or Equal to (>=) 5 Percent (%) From Baseline at Week 28: Part A
기간: Baseline, Week 28
Baseline, Week 28
Number of Participants With Reduction in Body Weight >= 10 % From Baseline at Week 28: Part A
기간: Baseline, Week 28
Baseline, Week 28
Number of Participants With Reduction in Body Weight >= 15 % From Baseline at Week 28: Part A
기간: Baseline, Week 28
Baseline, Week 28
Change From Baseline in Body Weight at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
기간: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Change From Baseline in Body Mass Index (BMI) at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
기간: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
BMI was derived from body weight in kilograms (kg) and height in meters (m), and it was calculated as weight divided by height^2.
Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Change From Baseline in Waist Circumference at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
기간: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Number of Participants With Gastrointestinal (GI) Adverse Event of Clinical Interest (AECI): Part A
기간: From Day 1 of dosing up to 28 days after last dose for Part A
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment. Gastrointestinal AECIs included nausea, vomiting and diarrhea.
From Day 1 of dosing up to 28 days after last dose for Part A
Number of Participants With Treatment Related Gastrointestinal AECIs: Part A
기간: From Day 1 of dosing up to 28 days after last dose for Part A
An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment. Gastrointestinal AECIs included nausea, vomiting and diarrhea. Treatment related gastrointestinal AECIs were GI AECIs that were related to study drug and relatedness was judged by investigator.
From Day 1 of dosing up to 28 days after last dose for Part A
Number of Participants With Gastrointestinal AECI and Treatment Related AECIs by Severity: Part A
기간: From Day 1 of dosing up to 28 days after last dose for Part A
An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment. Gastrointestinal AECIs included nausea, vomiting and diarrhea. Treatment related GI AECIs were GI AECIs that were related to study drug and relatedness was judged by investigator. Severity was assessed as mild: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; moderate: minimal, local or non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily living and severe: medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living or life-threatening consequences, urgent intervention indicated or death related to an AE.
From Day 1 of dosing up to 28 days after last dose for Part A
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs: Part A
기간: Up to Week 37
An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which does not necessarily have a causal relationship with the treatment. A TEAE was defined as any AE which on or after exposure to study treatment. Treatment related TEAEs were TEAEs that were related to study drug and relatedness was judged by investigator.
Up to Week 37
Number of Participants With TEAEs and Treatment-Related TEAEs by Severity: Part A
기간: Up to Week 37
An AE was defined as any untoward medical occurrence in participant administered an investigational product and which does not necessarily have causal relationship with treatment. A TEAE was defined as any AE which on or after exposure to study treatment up to 28 days following the last dose. Treatment related TEAEs were TEAEs that were related to study drug and relatedness was judged by investigator. Severity: mild: asymptomatic/ mild symptoms, clinical/ diagnostic observations only, intervention not indicated; moderate: minimal, local/ non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily living and severe: medically significant but not immediately life-threatening, hospitalization/ prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living/ life-threatening consequences, urgent intervention indicated/ death related to an AE.
Up to Week 37
Number of Participants With Abnormal Clinically Significant Physical Examination: Part A
기간: From Day 1 of dosing up to post treatment follow up for Part A
The physical examination included examination of the following body systems (at minimum): head and neck (including complete thyroid exam), cardiovascular, respiratory, gastrointestinal, brief neurological, and general appearance. Clinical significance will be judged by investigator.
From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: Part A
기간: From Day 1 of dosing up to post treatment follow up for Part A
Twelve lead ECGs were measured with the participant in a supine position after at least 5 minutes. Clinical significance will be judged by investigator.
From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants With Potential Clinically Significant Laboratory Values: Part A
기간: From Day 1 of dosing up to post treatment follow up for Part A
Laboratory parameters assessed included alanine aminotransferase (ALT) (units per liter [U/L]): greater than (>) 1*upper limit of normal (ULN), >3*ULN and >5*ULN; alkaline phosphatase (ALP) (U/L): >2*ULN; amylase (U/L): >1*ULN and >3*ULN; aspartate aminotransferase (AST): >1*ULN, >3*ULN and >5*ULN; estimated glomerular filtration rate (eGFR) (Ckd-Epi [chronic kidney disease epidemiology collaboration]) (milliliter per minute per 1.73m^2): less than (<) 60 mL/min/1.73m^2, 60-90 mL/min/1.73m^2 and >90 mL/min/1.73m^2; Lipase: >1*ULN and >3*ULN; neutrophils: <1.5, <0.5, 0.5 to <1, 1 to <1.5 and total bilirubin (milligrams per deciliter): >2* upper limit of normal (ULN). Potential clinical significance was judged by investigator.
From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Categories: Part A
기간: From Day 1 of dosing up to post treatment follow up for Part A
The C-SSRS is a questionnaire designed for the assessment of suicidal ideation and behavior in adolescents and adults. C-SSRS were evaluated through category 1 to 10. Suicidal ideation score was defined as the maximum suicidal ideation category (i.e., category 1-5), with 0 assigned if no ideation was present. Suicidal ideation, defined as 'Yes' if 'Yes' was present in any of category 1-5 and suicidal behavior, defined as 'Yes' if 'Yes' was present in any of category 6-10 and suicidal ideation or behavior, defined as 'Yes' if 'Yes' was present in any of Category 1-10.
From Day 1 of dosing up to post treatment follow up for Part A
Patient Health Questionnaire-9 (PHQ-9) Total Score: Part A
기간: From Day 1 of dosing up to post treatment follow up for Part A
The PHQ-9 is a questionnaire designed to monitor and measure the severity of depression in participants. The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead". Each item was scored on scale of "0=not at all", "several days", "more than half the days" to "nearly every day". The total score ranges from 0 to 27 by adding score for each question (total points) where: Score 1-4: minimal depression; Score 5-9: Mild depression; Score 10-14: moderate depression; Score 15-19 moderately severe depression; Score 20-27: Severe depression. Higher score indicates greater severity of depression.
From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants With Anti Drug Antibodies (ADAs): Part A
기간: From Day 1 of dosing up to post treatment follow up for Part A
Number of participants with baseline, positive and negative ADAs are reported in this outcome measure.
From Day 1 of dosing up to post treatment follow up for Part A
Minimum Observed Concentration (Cmin) of Berobenatide: Part A
기간: From pre-dose on Day 1 up to 168 hours post-dose
From pre-dose on Day 1 up to 168 hours post-dose
Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of Berobenatide: Part A
기간: From pre-dose on Day 1 up to 168 hours post-dose
AUCtau was area under the concentration versus time curve during the dosing interval (tau), where, tau=168 hours.
From pre-dose on Day 1 up to 168 hours post-dose
Maximum Observed Concentration (Cmax) of Berobenatide: Part A
기간: From pre-dose on Day 1 up to 168 hours post-dose
Cmax was observed directly from data.
From pre-dose on Day 1 up to 168 hours post-dose
Time to Maximum Concentration (Tmax) of Berobenatide: Part A
기간: From pre-dose on Day 1 up to 168 hours post-dose
From pre-dose on Day 1 up to 168 hours post-dose
Plasma Concentration of Berobenatide: Part A
기간: From pre-dose on Day 1 up to 168 hours post-dose
From pre-dose on Day 1 up to 168 hours post-dose
Percent Change From Baseline in Body Weight: Part B
기간: Baseline (last available measurement prior to first dose received in Part A), End of study
Baseline (last available measurement prior to first dose received in Part A), End of study
Number of Participants With TEAEs: Part B
기간: From Day 1 of dosing in Part B up to 28 days after last dose for Part B
An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which does not necessarily have a causal relationship with the treatment. A TEAE was defined as any AE which on or after exposure to study treatment up to 28 days following the last dose.
From Day 1 of dosing in Part B up to 28 days after last dose for Part B

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

수사관

  • 연구 책임자: Pfizer CT.gov Call Center, Pfizer

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)

2024년 10월 9일

기본 완료 (실제)

2025년 7월 3일

연구 완료 (실제)

2026년 4월 30일

연구 등록 날짜

최초 제출

2024년 11월 27일

QC 기준을 충족하는 최초 제출

2024년 11월 27일

처음 게시됨 (실제)

2024년 12월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 6일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • VESPER-1 (MET097-24-201)
  • C6491004 (기타 식별자: Alias Study Number)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

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