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A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly Compared to Placebo in Chinese Adults With Overweight or Obesity

4 november 2026 uppdaterad av: Pfizer

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

432

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230011
        • Har inte rekryterat ännu
        • The Second People's Hospital of Hefei
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100044
        • Har inte rekryterat ännu
        • Peking University People's Hospital
    • Guangdong
      • Huizhou, Guangdong, Kina, 516001
        • Har inte rekryterat ännu
        • Huizhou Central People's Hospital
    • Henan
      • Zhengzhou, Henan, Kina, 450014
        • Har inte rekryterat ännu
        • The Second Affiliated Hospital of Zhengzhou University
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210011
        • Rekrytering
        • The Second Affiliated Hospital of Nanjing Medical University
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330038
        • Har inte rekryterat ännu
        • Jiangxi Provincial People's Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo

Participants will receive matching placebo by Subcutaneous Injection.
Övrig: Placebo

By Subcutaneous Injection
Experimentell: Treatment Arm 1

Participants will receive Berobenatide by Subcutaneous Injection.
Läkemedel: Berobenatide

By Subcutaneous Injection

Andra namn:
  • PF-08653944
Experimentell: Treatment Arm 2

Participants will receive Berobenatide by Subcutaneous Injection.
Läkemedel: Berobenatide

By Subcutaneous Injection

Andra namn:
  • PF-08653944
Experimentell: Treatment Arm 3

Participants will receive Berobenatide by Subcutaneous Injection.
Läkemedel: Berobenatide

By Subcutaneous Injection

Andra namn:
  • PF-08653944
Experimentell: Treatment Arm 4

Participants will receive Berobenatide by Subcutaneous Injection.
Läkemedel: Berobenatide

By Subcutaneous Injection

Andra namn:
  • PF-08653944

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Percent change from baseline in body weight
Tidsram: Baseline, Week 48
Baseline, Week 48

Sekundära resultatmått

Resultatmått
Tidsram
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Tidsram: Baseline, Week 48
Baseline, Week 48
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Tidsram: Baseline, Week 48
Baseline, Week 48
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Tidsram: Baseline, Week 48
Baseline, Week 48
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in waist circumference
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in Fasting triglycerides
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in Systolic Blood Pressure (SBP)
Tidsram: 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
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in Diastolic Blood Pressure (DBP)
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in Low-density lipoprotein cholesterol
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in Very low-density lipoprotein cholesterol
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in High-density lipoprotein cholesterol
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from Baseline in HbA1c
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Physical Composite
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Psychosocial Composite
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in SF-36 domain scales and component summary scales
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from Baseline in Body mass index (BMI)
Tidsram: Baseline, Week 48
Baseline, Week 48
Percent change from baseline in body weight in participants without T2D
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in body weight
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in Non-high-density lipoprotein-cholesterol
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in Short-Form 36 health survey (SF-36) Physical Function domain score
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in Total Cholesterol
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from Baseline in Fasting plasma glucose
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from Baseline in Fasting insulin
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in High-sensitivity C-reactive protein (hs-CRP)
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in Interleukin (IL)-6
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in IL-1 beta
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from Baseline in HbA1c in participants with T2D
Tidsram: Baseline, Week 48
Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <7.0%
Tidsram: Baseline, Week 48
Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <6.5%
Tidsram: Baseline, Week 48
Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <5.7%
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in IWQoL-Lite-CT total score
Tidsram: Baseline, Week 48
Baseline, Week 48
Change from baseline in EuroQoL5-Dimension 5-Level (EQ-5D-5L) index score
Tidsram: Baseline, Week 48
Baseline, Week 48
Incidence proportion of Treatment-emergent adverse event (TEAE)
Tidsram: Up to Week 55
Up to Week 55
Incidence proportion of Serious adverse event (SAE)
Tidsram: Up to Week 55
Up to Week 55
Incidence proportion of Adverse event (AE) leading to permanent discontinuation from study intervention or study
Tidsram: Up to Week 55
Up to Week 55
Incidence proportion of Adverse events of special interest (AESIs)
Tidsram: Up to Week 55
Up to Week 55
Incidence proportion of Clinical laboratory abnormalities
Tidsram: Up to Week 55
Up to Week 55

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Utredare

  • Studierektor: Pfizer CT.gov Call Center, Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 oktober 2026

Primärt slutförande (Beräknad)

6 juni 2028

Avslutad studie (Beräknad)

15 augusti 2028

Studieregistreringsdatum

Först inskickad

29 september 2026

Först inskickad som uppfyllde QC-kriterierna

9 oktober 2026

Första postat (Faktisk)

15 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • C6491029

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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