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.
Přehled studie
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Pfizer CT.gov Call Center
- Telefonní číslo: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studijní místa
-
-
Anhui
-
Hefei, Anhui, Čína, 230011
- Zatím nenabíráme
- The Second People's Hospital of Hefei
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Beijing Municipality
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Beijing, Beijing Municipality, Čína, 100044
- Zatím nenabíráme
- Peking University People's Hospital
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Guangdong
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Huizhou, Guangdong, Čína, 516001
- Zatím nenabíráme
- Huizhou Central People's Hospital
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Henan
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Zhengzhou, Henan, Čína, 450014
- Zatím nenabíráme
- The Second Affiliated Hospital of Zhengzhou University
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Jiangsu
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Nanjing, Jiangsu, Čína, 210011
- Nábor
- The Second Affiliated Hospital of Nanjing Medical University
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Jiangxi
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Nanchang, Jiangxi, Čína, 330038
- Zatím nenabíráme
- Jiangxi Provincial People's Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: Placebo
Participants will receive matching placebo by Subcutaneous Injection. |
By Subcutaneous Injection |
|
Experimentální: Treatment Arm 1
Participants will receive Berobenatide by Subcutaneous Injection. |
By Subcutaneous Injection
Ostatní jména:
|
|
Experimentální: Treatment Arm 2
Participants will receive Berobenatide by Subcutaneous Injection. |
By Subcutaneous Injection
Ostatní jména:
|
|
Experimentální: Treatment Arm 3
Participants will receive Berobenatide by Subcutaneous Injection. |
By Subcutaneous Injection
Ostatní jména:
|
|
Experimentální: Treatment Arm 4
Participants will receive Berobenatide by Subcutaneous Injection. |
By Subcutaneous Injection
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Percent change from baseline in body weight
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in waist circumference
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Fasting triglycerides
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Systolic Blood Pressure (SBP)
Časové okno: 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
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Diastolic Blood Pressure (DBP)
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Low-density lipoprotein cholesterol
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Very low-density lipoprotein cholesterol
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in High-density lipoprotein cholesterol
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in HbA1c
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in IWQoL-Lite-CT Physical Composite
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in IWQoL-Lite-CT Psychosocial Composite
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in SF-36 domain scales and component summary scales
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in Body mass index (BMI)
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Percent change from baseline in body weight in participants without T2D
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in body weight
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Non-high-density lipoprotein-cholesterol
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Short-Form 36 health survey (SF-36) Physical Function domain score
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Total Cholesterol
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in Fasting plasma glucose
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in Fasting insulin
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in High-sensitivity C-reactive protein (hs-CRP)
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Interleukin (IL)-6
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in IL-1 beta
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in HbA1c in participants with T2D
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of participants with T2D at screening achieving HbA1c <7.0%
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of participants with T2D at screening achieving HbA1c <6.5%
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of participants with T2D at screening achieving HbA1c <5.7%
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in IWQoL-Lite-CT total score
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in EuroQoL5-Dimension 5-Level (EQ-5D-5L) index score
Časové okno: Baseline, Week 48
|
Baseline, Week 48
|
|
Incidence proportion of Treatment-emergent adverse event (TEAE)
Časové okno: Up to Week 55
|
Up to Week 55
|
|
Incidence proportion of Serious adverse event (SAE)
Časové okno: Up to Week 55
|
Up to Week 55
|
|
Incidence proportion of Adverse event (AE) leading to permanent discontinuation from study intervention or study
Časové okno: Up to Week 55
|
Up to Week 55
|
|
Incidence proportion of Adverse events of special interest (AESIs)
Časové okno: Up to Week 55
|
Up to Week 55
|
|
Incidence proportion of Clinical laboratory abnormalities
Časové okno: Up to Week 55
|
Up to Week 55
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- C6491029
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
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.
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