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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Pfizer CT.gov Call Center
- Numéro de téléphone: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Lieux d'étude
-
-
Anhui
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Hefei, Anhui, Chine, 230011
- Pas encore de recrutement
- The Second People's Hospital of Hefei
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100044
- Pas encore de recrutement
- Peking University People's Hospital
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Guangdong
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Huizhou, Guangdong, Chine, 516001
- Pas encore de recrutement
- Huizhou Central People's Hospital
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Henan
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Zhengzhou, Henan, Chine, 450014
- Pas encore de recrutement
- The Second Affiliated Hospital of Zhengzhou University
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Jiangsu
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Nanjing, Jiangsu, Chine, 210011
- Recrutement
- The Second Affiliated Hospital of Nanjing Medical University
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Jiangxi
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Nanchang, Jiangxi, Chine, 330038
- Pas encore de recrutement
- Jiangxi Provincial People's Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo
Participants will receive matching placebo by Subcutaneous Injection. |
By Subcutaneous Injection |
|
Expérimental: Treatment Arm 1
Participants will receive Berobenatide by Subcutaneous Injection. |
By Subcutaneous Injection
Autres noms:
|
|
Expérimental: Treatment Arm 2
Participants will receive Berobenatide by Subcutaneous Injection. |
By Subcutaneous Injection
Autres noms:
|
|
Expérimental: Treatment Arm 3
Participants will receive Berobenatide by Subcutaneous Injection. |
By Subcutaneous Injection
Autres noms:
|
|
Expérimental: Treatment Arm 4
Participants will receive Berobenatide by Subcutaneous Injection. |
By Subcutaneous Injection
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Percent change from baseline in body weight
Délai: Baseline, Week 48
|
Baseline, Week 48
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in waist circumference
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Fasting triglycerides
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Systolic Blood Pressure (SBP)
Délai: 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
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Diastolic Blood Pressure (DBP)
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Low-density lipoprotein cholesterol
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Very low-density lipoprotein cholesterol
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in High-density lipoprotein cholesterol
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in HbA1c
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in IWQoL-Lite-CT Physical Composite
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in IWQoL-Lite-CT Psychosocial Composite
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in SF-36 domain scales and component summary scales
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in Body mass index (BMI)
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Percent change from baseline in body weight in participants without T2D
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in body weight
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Non-high-density lipoprotein-cholesterol
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Short-Form 36 health survey (SF-36) Physical Function domain score
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Total Cholesterol
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in Fasting plasma glucose
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in Fasting insulin
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in High-sensitivity C-reactive protein (hs-CRP)
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in Interleukin (IL)-6
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in IL-1 beta
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from Baseline in HbA1c in participants with T2D
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of participants with T2D at screening achieving HbA1c <7.0%
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of participants with T2D at screening achieving HbA1c <6.5%
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Percentage of participants with T2D at screening achieving HbA1c <5.7%
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in IWQoL-Lite-CT total score
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Change from baseline in EuroQoL5-Dimension 5-Level (EQ-5D-5L) index score
Délai: Baseline, Week 48
|
Baseline, Week 48
|
|
Incidence proportion of Treatment-emergent adverse event (TEAE)
Délai: Up to Week 55
|
Up to Week 55
|
|
Incidence proportion of Serious adverse event (SAE)
Délai: Up to Week 55
|
Up to Week 55
|
|
Incidence proportion of Adverse event (AE) leading to permanent discontinuation from study intervention or study
Délai: Up to Week 55
|
Up to Week 55
|
|
Incidence proportion of Adverse events of special interest (AESIs)
Délai: Up to Week 55
|
Up to Week 55
|
|
Incidence proportion of Clinical laboratory abnormalities
Délai: Up to Week 55
|
Up to Week 55
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- C6491029
Plan pour les données individuelles des participants (IPD)
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Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
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