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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 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

432

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo

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

By Subcutaneous Injection
Eksperimentell: Treatment Arm 1

Participants will receive Berobenatide by Subcutaneous Injection.
Legemiddel: Berobenatide

By Subcutaneous Injection

Andre navn:
  • PF-08653944
Eksperimentell: Treatment Arm 2

Participants will receive Berobenatide by Subcutaneous Injection.
Legemiddel: Berobenatide

By Subcutaneous Injection

Andre navn:
  • PF-08653944
Eksperimentell: Treatment Arm 3

Participants will receive Berobenatide by Subcutaneous Injection.
Legemiddel: Berobenatide

By Subcutaneous Injection

Andre navn:
  • PF-08653944
Eksperimentell: Treatment Arm 4

Participants will receive Berobenatide by Subcutaneous Injection.
Legemiddel: Berobenatide

By Subcutaneous Injection

Andre navn:
  • PF-08653944

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Percent change from baseline in body weight
Tidsramme: Baseline, Week 48
Baseline, Week 48

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. oktober 2026

Primær fullføring (Antatt)

6. juni 2028

Studiet fullført (Antatt)

15. august 2028

Datoer for studieregistrering

Først innsendt

29. september 2026

Først innsendt som oppfylte QC-kriteriene

9. oktober 2026

Først lagt ut (Faktiske)

15. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C6491029

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere