A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly Compared to Placebo in Chinese Adults With Overweight or Obesity
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF 08653944 IN CHINESE ADULTS WITH OVERWEIGHT OR OBESITY
Overweight and obesity are long-term health conditions that can increase the possibility of serious health problems. These problems include heart disease, type 2 diabetes (a condition that causes high blood sugar), and other medical conditions. The purpose of this study is to learn whether berobenatide (PF-08653944) is safe and effective for adults in China who are overweight or obese. Researchers will compare berobenatide with a placebo. A placebo looks like study treatment but does not contain active medicine.
About 432 adults will take part in this study. This study is seeking adults who
- are obese
- are overweight with certain weight-related health conditions. Some participants may also have type 2 diabetes. Specific eligibility requirements will be reviewed by the study doctor before enrollment.
Participants will be randomly assigned to receive either berobenatide or placebo. Study treatment will be administered as a shot under the skin. All participants will also receive lifestyle counseling throughout the study.
Researchers will monitor participants throughout the study. They will assess participants' body weight, overall health, and any reactions that may occur. During the study, participants will attend study visits and complete study-related assessments.
Participants may take part in the study for up to approximately 59 weeks. This period includes screening, treatment, and follow-up visits. The information learned from this study may help researchers better understand whether berobenatide could be a treatment option for adults living with overweight or obesity.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 3
連絡先と場所
研究連絡先
研究連絡先
- 名前：Pfizer CT.gov Call Center
- 電話番号：1-800-718-1021
- メール：ClinicalTrials.gov_Inquiries@pfizer.com
研究場所
-
-
Anhui
-
Hefei、Anhui、中国、230011
- まだ募集していません
- The Second People's Hospital of Hefei
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100044
- まだ募集していません
- Peking University People's Hospital
-
-
Guangdong
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Huizhou、Guangdong、中国、516001
- まだ募集していません
- Huizhou Central People's Hospital
-
-
Henan
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Zhengzhou、Henan、中国、450014
- まだ募集していません
- The Second Affiliated Hospital of Zhengzhou University
-
-
Jiangsu
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Nanjing、Jiangsu、中国、210011
- 募集
- The Second Affiliated Hospital of Nanjing Medical University
-
-
Jiangxi
-
Nanchang、Jiangxi、中国、330038
- まだ募集していません
- Jiangxi Provincial People's Hospital
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults ≥18 years of age.
- BMI ≥28 kg/m²; or BMI ≥24 kg/m² and <28 kg/m² with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.
- At least one prior unsuccessful dietary weight-loss attempt.
Exclusion Criteria:
- Significant recent weight change (>5% within 3 months).
- Type 1 diabetes mellitus.
- History of pancreatitis.
- Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple endocrine neoplasia type 2 (MEN2).
- Recent bariatric surgery or obesity procedures.
- Pregnancy or breastfeeding.
研究計画
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
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
プラセボコンパレーター：Placebo
Participants will receive matching placebo by Subcutaneous Injection. |
By Subcutaneous Injection |
|
実験的：Treatment Arm 1
Participants will receive Berobenatide by Subcutaneous Injection. |
By Subcutaneous Injection
他の名前：
|
|
実験的：Treatment Arm 2
Participants will receive Berobenatide by Subcutaneous Injection. |
By Subcutaneous Injection
他の名前：
|
|
実験的：Treatment Arm 3
Participants will receive Berobenatide by Subcutaneous Injection. |
By Subcutaneous Injection
他の名前：
|
|
実験的：Treatment Arm 4
Participants will receive Berobenatide by Subcutaneous Injection. |
By Subcutaneous Injection
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Percent change from baseline in body weight
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
二次結果の測定
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Percentage of Participants achieving ≥5% of body weight reduction from baseline
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of Participants achieving ≥10% of body weight reduction from baseline
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of Participants achieving ≥15% of body weight reduction from baseline
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of Participants achieving ≥20% of body weight reduction from baseline
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in waist circumference
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Fasting triglycerides
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Systolic Blood Pressure (SBP)
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Diastolic Blood Pressure (DBP)
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Low-density lipoprotein cholesterol
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Very low-density lipoprotein cholesterol
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in High-density lipoprotein cholesterol
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in HbA1c
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in IWQoL-Lite-CT Physical Composite
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in IWQoL-Lite-CT Psychosocial Composite
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in SF-36 domain scales and component summary scales
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in Body mass index (BMI)
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Percent change from baseline in body weight in participants without T2D
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in body weight
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Non-high-density lipoprotein-cholesterol
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Short-Form 36 health survey (SF-36) Physical Function domain score
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Total Cholesterol
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in Fasting plasma glucose
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in Fasting insulin
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in High-sensitivity C-reactive protein (hs-CRP)
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Interleukin (IL)-6
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in IL-1 beta
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in HbA1c in participants with T2D
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of participants with T2D at screening achieving HbA1c <7.0%
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of participants with T2D at screening achieving HbA1c <6.5%
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of participants with T2D at screening achieving HbA1c <5.7%
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in IWQoL-Lite-CT total score
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in EuroQoL5-Dimension 5-Level (EQ-5D-5L) index score
時間枠：Baseline, Week 48
|
Baseline, Week 48
|
|
Incidence proportion of Treatment-emergent adverse event (TEAE)
時間枠：Up to Week 55
|
Up to Week 55
|
|
Incidence proportion of Serious adverse event (SAE)
時間枠：Up to Week 55
|
Up to Week 55
|
|
Incidence proportion of Adverse event (AE) leading to permanent discontinuation from study intervention or study
時間枠：Up to Week 55
|
Up to Week 55
|
|
Incidence proportion of Adverse events of special interest (AESIs)
時間枠：Up to Week 55
|
Up to Week 55
|
|
Incidence proportion of Clinical laboratory abnormalities
時間枠：Up to Week 55
|
Up to Week 55
|
協力者と研究者
捜査官
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
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- C6491029
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?
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
米国FDA規制機器製品の研究
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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。