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

7. juli 2026 opdateret af: 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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

872

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Canada
    • Nova Scotia
      • Bridgewater, Nova Scotia, Canada, B4V 3N2
        • Ikke rekrutterer endnu
        • Viable Clinical Research Corporation
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Ikke rekrutterer endnu
        • Aggarwal and Associates Limited
      • Etobicoke, Ontario, Canada, M9R 4E1
        • Ikke rekrutterer endnu
        • Centricity Research Etobicoke Endocrinology
      • London, Ontario, Canada, N5W 6A2
        • Ikke rekrutterer endnu
        • Milestone Research Inc.
      • Sarnia, Ontario, Canada, N7T 4X3
        • Ikke rekrutterer endnu
        • Bluewater Clinical Research Group Inc.
      • Toronto, Ontario, Canada, M9V 4B4
        • Rekruttering
        • Dr. Anil K. Gupta Medicine Professional Corporation
      • Toronto, Ontario, Canada, M9W 4L6
        • Ikke rekrutterer endnu
        • Centricity Research Toronto Manna Multispecialty
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ikke rekrutterer endnu
        • Ecogene-21
      • Mirabel, Quebec, Canada, J7J 2K8
        • Ikke rekrutterer endnu
        • Centricity Research Mirabel Multispecialty
      • Montreal, Quebec, Canada, H1Y 3H5
        • Ikke rekrutterer endnu
        • Recherche GCP Research
  • Forenede Stater
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85225
        • Rekruttering
        • Arizona Clinical Trials-Chandler
      • Sun City West, Arizona, Forenede Stater, 85375
        • Rekruttering
        • Clinical Research Institute of Arizona
      • Tucson, Arizona, Forenede Stater, 85711
        • Rekruttering
        • Arizona Clinical Trials (ACT) - Tucson
    • California
      • Canoga Park, California, Forenede Stater, 91304
        • Rekruttering
        • San Fernando Valley Health Institute
      • Fountain Valley, California, Forenede Stater, 92708
        • Rekruttering
        • Ark Clinical Research
      • Garden Grove, California, Forenede Stater, 92840
        • Rekruttering
        • Paragon Rx Clinical
      • Lomita, California, Forenede Stater, 90717
        • Rekruttering
        • Torrance Clinical Research Institute, Inc.
      • Long Beach, California, Forenede Stater, 90815
        • Rekruttering
        • Ark Clinical Research
      • Los Alamitos, California, Forenede Stater, 90720
        • Rekruttering
        • Collaborative Neuroscience Research, LLC
      • Modesto, California, Forenede Stater, 95355
        • Rekruttering
        • Paradigm Clinical Research-Modesto
      • San Diego, California, Forenede Stater, 92108
        • Rekruttering
        • Paradigm Clinical Research Centers, LLC
      • Tustin, California, Forenede Stater, 92780
        • Rekruttering
        • University Clinical Investigators, Incorporated
      • Walnut Creek, California, Forenede Stater, 94598
        • Rekruttering
        • Diablo Clinical Research, LLC dba Flourish Research
    • Florida
      • Hialeah, Florida, Forenede Stater, 33012
        • Rekruttering
        • AGA Clinical Trials
      • Jacksonville, Florida, Forenede Stater, 32205
        • Rekruttering
        • Westside Center for Clinical Research
      • Miami, Florida, Forenede Stater, 33165
        • Rekruttering
        • New Horizon Research Center
      • Orlando, Florida, Forenede Stater, 32803
        • Rekruttering
        • Charter Research
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30318
        • Rekruttering
        • Atlanta Diabetes Associates
      • Stockbridge, Georgia, Forenede Stater, 30281
        • Rekruttering
        • Clinical Research Atlanta
    • Illinois
      • Morton, Illinois, Forenede Stater, 61550
        • Rekruttering
        • Koch Family Medicine Clinical Research/Elite Research Network
      • Naperville, Illinois, Forenede Stater, 60540
        • Rekruttering
        • Bioluminux Clinical Research Illinois
    • Kansas
      • Lenexa, Kansas, Forenede Stater, 66219
        • Rekruttering
        • Johnson County Clinical Trials
    • Louisiana
      • Mandeville, Louisiana, Forenede Stater, 70471
        • Rekruttering
        • DelRicht Research
      • Prairieville, Louisiana, Forenede Stater, 70769
        • Rekruttering
        • DelRicht Research
    • Maryland
      • Lutherville, Maryland, Forenede Stater, 21093
        • Rekruttering
        • Patient First Clinical Trials (PFCTRIALS)
    • Missouri
      • Springfield, Missouri, Forenede Stater, 65807
        • Rekruttering
        • DelRicht Research
    • Montana
      • Butte, Montana, Forenede Stater, 59701
        • Rekruttering
        • Mercury Street Medical Group, PLLC
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Rekruttering
        • AB Clinical Trials
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Rekruttering
        • Palm Research Center
      • Las Vegas, Nevada, Forenede Stater, 89109
        • Rekruttering
        • Alliance Clinical Research Las Vegas (Excel Clinical Research)
    • New Jersey
      • Hamilton, New Jersey, Forenede Stater, 08690
        • Rekruttering
        • Bioluminux Clinical Research
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28210
        • Rekruttering
        • DelRicht Research
      • Monroe, North Carolina, Forenede Stater, 28112
        • Rekruttering
        • Monroe Biomedical Research
      • Statesville, North Carolina, Forenede Stater, 28625
        • Rekruttering
        • Piedmont Healthcare
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Rekruttering
        • Accellacare - Wilmington
    • Oklahoma
      • Edmond, Oklahoma, Forenede Stater, 73013
        • Rekruttering
        • Tekton Research, LLC.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15236
        • Rekruttering
        • Preferred Primary Care Physicians
      • Uniontown, Pennsylvania, Forenede Stater, 15401
        • Rekruttering
        • Preferred Primary Care Physicians
      • Uniontown, Pennsylvania, Forenede Stater, 15401
        • Rekruttering
        • Preferred Primary Care Physicians, Inc.
    • South Carolina
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
        • Rekruttering
        • TMA Headlands LLC (d/b/a Trial Management Associates)
    • Tennessee
      • Hendersonville, Tennessee, Forenede Stater, 37075
        • Rekruttering
        • DelRicht Research
    • Texas
      • Euless, Texas, Forenede Stater, 76040
        • Rekruttering
        • Cedar Health Research - Euless
      • Houston, Texas, Forenede Stater, 77040
        • Rekruttering
        • JCCT-JUNO NW Houston
      • Kingwood, Texas, Forenede Stater, 77339
        • Rekruttering
        • Activian Clinical Research
      • Plano, Texas, Forenede Stater, 75093
        • Rekruttering
        • 3A Research
      • Prosper, Texas, Forenede Stater, 75078
        • Rekruttering
        • DelRicht Research @ Zomnir Family Medicine
      • San Antonio, Texas, Forenede Stater, 78217
        • Rekruttering
        • Worldwide Clinical Trials
      • San Antonio, Texas, Forenede Stater, 78258
        • Rekruttering
        • Tekton Research, LLC.
      • Shavano Park, Texas, Forenede Stater, 78231
        • Rekruttering
        • Consano Clinical Research, LLC
      • Tomball, Texas, Forenede Stater, 77375
        • Rekruttering
        • DM Clinical Research
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84107
        • Rekruttering
        • Wasatch Clinical Research, LLC
      • Salt Lake City, Utah, Forenede Stater, 84102
        • Rekruttering
        • Alpine Medical Group
    • Virginia
      • Arlington, Virginia, Forenede Stater, 22206
        • Rekruttering
        • Washington Center for Weight Management and Research
      • Manassas, Virginia, Forenede Stater, 20110
        • Rekruttering
        • Manassas Clinical Research Center
      • Vienna, Virginia, Forenede Stater, 22182
        • Rekruttering
        • DelRicht Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1
Participants receive subcutaneous injections of PF-08653945 or placebo.
Medicin: Placebo
Subkutan injektion
Medicin: PF-08653945
Subcutaneous Injection
Eksperimentel: Cohort 2
Participants receive subcutaneous injections of PF-08653945 + PF-08653944 or placebo.
Medicin: Placebo
Subkutan injektion
Medicin: PF-08653944
Subkutan injektion
Medicin: PF-08653945
Subcutaneous Injection
Eksperimentel: Cohort 3
Participants receive subcutaneous injections of PF-08653945 + PF-08653944 , PF-08653944 , or placebo.
Medicin: Placebo
Subkutan injektion
Medicin: PF-08653944
Subkutan injektion
Medicin: PF-08653945
Subcutaneous Injection

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. maj 2026

Primær færdiggørelse (Anslået)

4. august 2027

Studieafslutning (Anslået)

5. januar 2028

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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