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A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)

9. september 2026 oppdatert av: Pfizer

A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, DOSE-RANGING, DOSE-FINDING, UMBRELLA STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08653945 AND PF-08653944, ALONE OR IN COMBINATION, IN ADULTS WITH OVERWEIGHT OR OBESITY (SOLIS-1)

This study is being done to learn about the safety and effects of the study drugs, PF-08653945 and PF-08653944, when given alone or together for weight loss, compared to a placebo (a dummy drug that has no active ingredient in it).

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

940

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • Nova Scotia
      • Bridgewater, Nova Scotia, Canada, B4V 3N2
        • Viable Clinical Research Corporation
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Aggarwal and Associates Limited
      • Etobicoke, Ontario, Canada, M9R 4E1
        • Centricity Research Etobicoke Endocrinology
      • London, Ontario, Canada, N5W 6A2
        • Milestone Research Inc.
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research Group Inc.
      • Toronto, Ontario, Canada, M9V 4B4
        • Dr. Anil K. Gupta Medicine Professional Corporation
      • Toronto, Ontario, Canada, M9W 4L6
        • Centricity Research Toronto Manna Multispecialty
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
      • Mirabel, Quebec, Canada, J7J 2K8
        • Centricity Research Mirabel Multispecialty
      • Montreal, Quebec, Canada, H1Y 3H5
        • Recherche GCP Research
  • Forente stater
    • Arizona
      • Sun City West, Arizona, Forente stater, 85375
        • Clinical Research Institute of Arizona
    • California
      • Canoga Park, California, Forente stater, 91304
        • San Fernando Valley Health Institute
      • Fountain Valley, California, Forente stater, 92708
        • ARK Clinical Research
      • Garden Grove, California, Forente stater, 92840
        • Paragon Rx Clinical
      • Lomita, California, Forente stater, 90717
        • Torrance Clinical Research Institute, Inc.
      • Long Beach, California, Forente stater, 90815
        • ARK Clinical Research
      • Los Alamitos, California, Forente stater, 90720
        • Collaborative Neuroscience Research, LLC
      • Modesto, California, Forente stater, 95355
        • Paradigm Clinical Research-Modesto
      • San Diego, California, Forente stater, 92108
        • Paradigm Clinical Research Centers, LLC
      • Tustin, California, Forente stater, 92780
        • University Clinical Investigators, Incorporated
      • Walnut Creek, California, Forente stater, 94598
        • Diablo Clinical Research, LLC dba Flourish Research
    • Florida
      • Hialeah, Florida, Forente stater, 33012
        • AGA Clinical Trials
      • Jacksonville, Florida, Forente stater, 32205
        • Westside Center for Clinical Research
      • Miami, Florida, Forente stater, 33165
        • New Horizon Research Center
      • Orlando, Florida, Forente stater, 32803
        • Charter Research
    • Georgia
      • Atlanta, Georgia, Forente stater, 30318
        • Atlanta Diabetes Associates
      • Stockbridge, Georgia, Forente stater, 30281
        • Clinical Research Atlanta
    • Illinois
      • Morton, Illinois, Forente stater, 61550
        • Koch Family Medicine Clinical Research/Elite Research Network
      • Naperville, Illinois, Forente stater, 60540
        • Bioluminux Clinical Research Illinois
    • Kansas
      • Lenexa, Kansas, Forente stater, 66219
        • Johnson County Clinical Trials
    • Louisiana
      • Mandeville, Louisiana, Forente stater, 70471
        • DelRicht Research
      • Prairieville, Louisiana, Forente stater, 70769
        • DelRicht Research
    • Maryland
      • Lutherville, Maryland, Forente stater, 21093
        • Patient First Clinical Trials (PFCTRIALS)
    • Missouri
      • Springfield, Missouri, Forente stater, 65807
        • DelRicht Research
    • Montana
      • Butte, Montana, Forente stater, 59701
        • Mercury Street Medical Group, PLLC
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89119
        • AB Clinical Trials
      • Las Vegas, Nevada, Forente stater, 89128
        • Palm Research Center
      • Las Vegas, Nevada, Forente stater, 89109
        • Alliance Clinical Research Las Vegas (Excel Clinical Research)
    • New Jersey
      • Hamilton, New Jersey, Forente stater, 08690
        • Bioluminux Clinical Research
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28211
        • DelRicht Research
      • Monroe, North Carolina, Forente stater, 28112
        • Monroe Biomedical Research
      • Statesville, North Carolina, Forente stater, 28625
        • Piedmont Healthcare
      • Wilmington, North Carolina, Forente stater, 28401
        • Accellacare - Wilmington
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73134
        • Tekton Research, LLC.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15236
        • Preferred Primary Care Physicians
      • Uniontown, Pennsylvania, Forente stater, 15401
        • Preferred Primary Care Physicians
      • Uniontown, Pennsylvania, Forente stater, 15401
        • Preferred Primary Care Physicians, Inc.
    • South Carolina
      • Myrtle Beach, South Carolina, Forente stater, 29572
        • TMA Headlands LLC (d/b/a Trial Management Associates)
    • Tennessee
      • Hendersonville, Tennessee, Forente stater, 37075
        • DelRicht Research
    • Texas
      • Euless, Texas, Forente stater, 76040
        • Cedar Health Research - Euless
      • Houston, Texas, Forente stater, 77040
        • JCCT-JUNO NW Houston
      • Kingwood, Texas, Forente stater, 77339
        • Activian Clinical Research
      • Plano, Texas, Forente stater, 75093
        • 3A Research
      • Prosper, Texas, Forente stater, 75078
        • DelRicht Research @ Zomnir Family Medicine
      • San Antonio, Texas, Forente stater, 78217
        • Worldwide Clinical Trials
      • San Antonio, Texas, Forente stater, 78258
        • Tekton Research, LLC.
      • Shavano Park, Texas, Forente stater, 78231
        • Consano Clinical Research, LLC
      • Tomball, Texas, Forente stater, 77375
        • DM Clinical Research
    • Utah
      • Salt Lake City, Utah, Forente stater, 84102
        • Alpine Medical Group
      • Salt Lake City, Utah, Forente stater, 84107
        • Wasatch Clinical Research, LLC
    • Virginia
      • Arlington, Virginia, Forente stater, 22206
        • Washington Center for Weight Management and Research
      • Manassas, Virginia, Forente stater, 20110
        • Manassas Clinical Research Center
      • Vienna, Virginia, Forente stater, 22182
        • DelRicht Research

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

Eligible participants for this study include:

  • adults aged 18 years or older with
  • obesity (BMI of 30.0 kg/m2 to 50.0 kg/m2) or with
  • overweight (BMI of 27.0 kg/m2 to <30.0 kg/m2) who also have at least 1 prespecified weight-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea), at the screening visit.

Exclusion Criteria:

Participants who are not eligible include those with diabetes mellitus, a body weight change of >5% or use of weight loss medications in the 12 weeks prior to screening, a history of or plan for surgical treatment for obesity, and those who are unable or unwilling to comply with contraceptive requirements or are pregnant or lactating.

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cohort 1
Participants receive subcutaneous injections of PF-08653945 or placebo.
Legemiddel: Placebo
Subkutan injeksjon
Legemiddel: PF-08653945
Subcutaneous Injection
Eksperimentell: Cohort 2
Participants receive subcutaneous injections of PF-08653945 + PF-08653944 or placebo.
Legemiddel: Placebo
Subkutan injeksjon
Legemiddel: PF-08653944
Subkutan injeksjon
Legemiddel: PF-08653945
Subcutaneous Injection
Eksperimentell: Cohort 3
Participants receive subcutaneous injections of PF-08653945 + PF-08653944 , PF-08653944 , or placebo.
Legemiddel: Placebo
Subkutan injeksjon
Legemiddel: PF-08653944
Subkutan injeksjon
Legemiddel: PF-08653945
Subcutaneous Injection

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Percent change from baseline in body weight
Tidsramme: Baseline (Week 0) to Week 48
Baseline (Week 0) to Week 48

Sekundære resultatmål

Resultatmål
Tidsramme
Percent change from baseline in body weight
Tidsramme: Baseline (Week 0) to Week 60
Baseline (Week 0) to Week 60
Change from baseline in body weight
Tidsramme: Baseline (Week 0) to Week 48 and Week 60
Baseline (Week 0) to Week 48 and Week 60
Percentage of participants who achieve ≥5% of body weight reduction from baseline
Tidsramme: Baseline (Week 0) to Week 48 and Week 60
Baseline (Week 0) to Week 48 and Week 60
Percentage of participants who achieve ≥10% of body weight reduction from baseline
Tidsramme: Baseline (Week 0) to Week 48 and Week 60
Baseline (Week 0) to Week 48 and Week 60
Percentage of participants who achieve ≥15% of body weight reduction from baseline
Tidsramme: Baseline (Week 0) to Week 48 and Week 60
Baseline (Week 0) to Week 48 and Week 60
Percentage of participants who achieve ≥20% of body weight reduction from baseline
Tidsramme: Baseline (Week 0) to Week 48 and Week 60
Baseline (Week 0) to Week 48 and Week 60
Percentage of participants who achieve ≥25% of body weight reduction from baseline
Tidsramme: Baseline (Week 0) to Week 48 and Week 60
Baseline (Week 0) to Week 48 and Week 60
Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Tidsramme: Up to Week 70
Up to Week 70

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)

11. mai 2026

Primær fullføring (Antatt)

4. august 2027

Studiet fullført (Antatt)

5. januar 2028

Datoer for studieregistrering

Først innsendt

4. mai 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

8. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C6511002
  • SOLIS-1 (Annen identifikator: Alias Study Number)

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

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