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週1回MET-097の4つの異なるレジメンの安全性と有効性を調べるための16週間の第2b相試験 (VESPER-1)

2026年8月6日 更新者：Pfizer

肥満および過体重の参加者における週1回MET097の4つの異なるレジメンの16週間の安全性と有効性を調査するためのフェーズ2b、多施設、無作為化、プラセボ対照二重盲検試験

この研究は、実薬である MET097 がプラセボと比較して、肥満または過体重の患者の治療にどの程度効果があるかをテストすることを目的としています。 MET097 またはプラセボは、16 週間にわたって毎週個人に投与されます。 個人が MET097 に割り当てられた場合、4 つの異なる線量レベルのうちの 1 つが投与されます。

調査の概要

状態

完了

条件

介入・治療

詳細な説明

これは、肥満または過体重（体格指数[BMI]）の成人参加者の体重減少に対する、4つの異なる用量レベルのMET097とプラセボの有効性と安全性を調査する多施設共同無作為化二重盲検プラセボ対照研究です。 】27～50kg/m2、18～70歳）、週1回16回投与。 すべての参加者は、安全性を確保するために、最後の週に1回の用量を投与した後、11週間（半減期約5）追跡されます。

研究の種類

介入

入学 (実際)

239

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • Anaheim、California、アメリカ、92801
        • Anaheim Clinical Trials, LLC
    • Florida
      • Hollywood、Florida、アメリカ、92801
        • Research Centers of America

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • スクリーニング時の肥満指数 (BMI):

    • BMI ≥30 kg/m2 かつ ≤50.0 kg/m2 (以下に挙げる体重関連の併存疾患がある可能性があります)

    • BMI ≧ 27.0 kg/m2 ～ < 30.0 kg/m2 で、以下の体重関連の併存疾患のうち少なくとも 1 つを有する：

      1. 高血圧：血圧（BP）降下薬を服用中、またはスクリーニング時に収縮期血圧が130 mmHg以上、または拡張期血圧が80 mmHg以上である
      2. 脂質異常症：脂質低下薬を服用中、または低密度リポタンパク質コレステロール（LDL-C）≧160 mg/dL（4.1 mmol/L）またはトリグリセリド≧150 mg/dL（1.7 mmol/L）、または高密度リポタンパク質を有する。男性の場合、コレステロール (HDL-C) <40 mg/dL (1.0 mmol/L) またはスクリーニング時の女性の HDL-C <50 mg/dL (1.3 mmol/L)

スクリーニング前の3か月以内に安定した体重（増加または減少が5kg以下）

除外基準:

  • 糖尿病 (T1DM または T2DM) または糖化ヘモグロビン A1c (HbA1c) ≥ 6.5% または空腹時血漿グルコース > 125 mg/dL の診断。
  • 推定糸球体濾過速度 (eGFR) <75 mL/min/1.73 平方メートル
  • 膵炎の病歴
  • 甲状腺髄様がん（MTC）または多発性内分泌腫瘍症候群2型（MEN-2）の家族歴または個人歴
  • 過去2年以内の重大な活動性または不安定性大うつ病性障害（MDD）またはその他の重度の精神障害の病歴
  • 生涯にわたる自殺未遂歴。

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：プラセボ
研究中は、無菌の 0.9% (w/v) 生理食塩水がプラセボ治療として使用されます。
薬：プラセボ
研究中は、無菌の 0.9% (w/v) 生理食塩水がプラセボ治療として使用されます。
実験的：MET097 アクティブ
MET097 は、4 つの異なる用量レベルで、滴定なしで週に 1 回皮下投与されます。 延長段階には、毎週より少ない頻度での投与計画が含まれます。
薬：MET097
MET097 は、超長時間作用型の完全にバイアスされたヒト GLP-1 アナログです。

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percent Change From Baseline in Body Weight at Week 28: Part A
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠：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
時間枠：Baseline, Week 28
Baseline, Week 28
Number of Participants With Reduction in Body Weight >= 10 % From Baseline at Week 28: Part A
時間枠：Baseline, Week 28
Baseline, Week 28
Number of Participants With Reduction in Body Weight >= 15 % From Baseline at Week 28: Part A
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pfizer

捜査官

  • スタディディレクター：Pfizer CT.gov Call Center、Pfizer

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年10月9日

一次修了 (実際)

2025年7月3日

研究の完了 (実際)

2026年4月30日

試験登録日

最初に提出

2024年11月27日

QC基準を満たした最初の提出物

2024年11月27日

最初の投稿 (実際)

2024年12月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月28日

QC基準を満たした最後の更新が送信されました

2026年8月6日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • VESPER-1 (MET097-24-201)
  • C6491004 (その他の識別子：Alias Study Number)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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