En 16-ukers fase 2b-studie for å undersøke sikkerheten og effekten av fire forskjellige regimer av MET-097 én gang i uken (VESPER-1)
6. august 2026 oppdatert av: Pfizer
En fase 2b, multisenter, randomisert, placebokontrollert dobbeltblind studie for å undersøke sikkerheten og effekten av 16 uker med fire forskjellige regimer med én gang i uken MET097 hos deltakere med fedme og overvekt
Denne studien er designet for å teste hvor godt MET097, et aktivt medikament, fungerer for å behandle personer med fedme eller overvekt sammenlignet med placebo.
MET097 eller placebo vil bli gitt til individer ukentlig i 16 uker.
Hvis en person blir tildelt MET097, vil de motta en av fire forskjellige dosenivåer.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Dette er en multisenter, randomisert, dobbeltblind, placebokontrollert studie for å undersøke effekten og sikkerheten til fire forskjellige dosenivåer av MET097 vs. placebo for kroppsvekttap hos voksne deltakere med fedme eller overvekt (kroppsmasseindeks [BMI] ] 27 til 50 kg/m2, i alderen 18 til 70 år), med 16 doser en gang i uken.
Alle deltakere vil bli fulgt i 11 uker (~5 halveringstider) etter administrering av den siste ukentlige dosen for sikkerhets skyld.
Studietype
Intervensjonell
Registrering (Faktiske)
239
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Anaheim, California, Forente stater, 92801
- Anaheim Clinical Trials, LLC
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Florida
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Hollywood, Florida, Forente stater, 92801
- Research Centers of America
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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
Inkluderingskriterier:
Kroppsmasseindeks (BMI) ved screening av:
- BMI ≥30 kg/m2 og ≤50,0 kg/m2 (kan ha de vektrelaterte komorbiditetene oppført nedenfor)
BMI ≥27,0 kg/m2 til <30,0 kg/m2 med minst én av følgende vektrelaterte komorbiditeter:
- Hypertensjon: på blodtrykkssenkende medisiner eller har systolisk BP ≥130 mmHg eller diastolisk BP ≥80 mmHg ved screening
- Dyslipidemi: på lipidsenkende medisiner eller med lavdensitetslipoproteinkolesterol (LDL-C) ≥160 mg/dL (4,1 mmol/L) eller triglyserider ≥150 mg/dL (1,7 mmol/L), eller høydensitetslipoprotein- kolesterol (HDL-C) <40 mg/dL (1,0 mmol/L) for menn eller HDL-C <50 mg/dL (1,3 mmol/L) for kvinner ved screening
Stabil kroppsvekt (økning eller reduksjon ≤5 kg) innen 3 måneder før screening
Ekskluderingskriterier:
- Diagnose av diabetes (T1DM eller T2DM) eller glykert hemoglobin A1c (HbA1c) ≥ 6,5 % eller fastende plasmaglukose >125 mg/dL.
- Estimert glomerulær filtrasjonshastighet (eGFR) <75 ml/min/1,73 m2
- Historie om pankreatitt
- Familie eller personlig historie med medullært skjoldbruskkjertelkarsinom (MTC) eller multippel endokrin neoplasi syndrom type 2 (MEN-2)
- Anamnese med betydelig aktiv eller ustabil alvorlig depressiv lidelse (MDD) eller annen alvorlig psykiatrisk lidelse i løpet av de siste 2 årene
- Enhver livshistorie med et selvmordsforsøk.
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 |
|---|---|
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Placebo komparator: Placebo
Sterilt 0,9 % (w/v) saltvann vil bli brukt som placebobehandling under studien.
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Sterilt 0,9 % (w/v) saltvann vil bli brukt som placebobehandling under studien.
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Eksperimentell: MET097 Aktiv
MET097 vil bli administrert i fire forskjellige dosenivåer subkutant en gang ukentlig uten titrering.
Forlengelsesfasen inkluderer doseringsregimer som er sjeldnere enn ukentlig.
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MET097 er en ultralangtidsvirkende, fullstendig partisk analog av human GLP-1.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percent Change From Baseline in Body Weight at Week 28: Part A
Tidsramme: Baseline (last non-missing measurement prior to the first dose), Week 28
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Analysis was performed using mixed model for repeated measures (MMRM) with treatment group, visit, and treatment by visit interaction, sex, and baseline body weight as fixed effects using unstructured covariance.
The analysis excluded weight measurements after protocol specified intercurrent events (ICEs) including permanent treatment discontinuation, non-compliance to treatment and lifestyle change.
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Baseline (last non-missing measurement prior to the first dose), Week 28
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percent Change From Baseline in Body Weight at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169: Part A
Tidsramme: Baseline, Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169
|
Analysis was performed using MMRM with treatment group, visit, and treatment by visit interaction, sex, and baseline body weight as fixed effects using unstructured covariance excluding weight measurements after protocol specified intercurrent ICEs.
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Baseline, Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169
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Number of Participants With Reduction in Body Weight Greater Than or Equal to (>=) 5 Percent (%) From Baseline at Week 28: Part A
Tidsramme: Baseline, Week 28
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Baseline, Week 28
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Number of Participants With Reduction in Body Weight >= 10 % From Baseline at Week 28: Part A
Tidsramme: Baseline, Week 28
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Baseline, Week 28
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Number of Participants With Reduction in Body Weight >= 15 % From Baseline at Week 28: Part A
Tidsramme: Baseline, Week 28
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Baseline, Week 28
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Change From Baseline in Body Weight at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
Tidsramme: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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Change From Baseline in Body Mass Index (BMI) at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
Tidsramme: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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BMI was derived from body weight in kilograms (kg) and height in meters (m), and it was calculated as weight divided by height^2.
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Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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Change From Baseline in Waist Circumference at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
Tidsramme: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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Number of Participants With Gastrointestinal (GI) Adverse Event of Clinical Interest (AECI): Part A
Tidsramme: From Day 1 of dosing up to 28 days after last dose for Part A
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An adverse event (AE) was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment.
Gastrointestinal AECIs included nausea, vomiting and diarrhea.
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From Day 1 of dosing up to 28 days after last dose for Part A
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Number of Participants With Treatment Related Gastrointestinal AECIs: Part A
Tidsramme: From Day 1 of dosing up to 28 days after last dose for Part A
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An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment.
Gastrointestinal AECIs included nausea, vomiting and diarrhea.
Treatment related gastrointestinal AECIs were GI AECIs that were related to study drug and relatedness was judged by investigator.
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From Day 1 of dosing up to 28 days after last dose for Part A
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Number of Participants With Gastrointestinal AECI and Treatment Related AECIs by Severity: Part A
Tidsramme: From Day 1 of dosing up to 28 days after last dose for Part A
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An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment.
Gastrointestinal AECIs included nausea, vomiting and diarrhea.
Treatment related GI AECIs were GI AECIs that were related to study drug and relatedness was judged by investigator.
Severity was assessed as mild: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; moderate: minimal, local or non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily living and severe: medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living or life-threatening consequences, urgent intervention indicated or death related to an AE.
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From Day 1 of dosing up to 28 days after last dose for Part A
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs: Part A
Tidsramme: Up to Week 37
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An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which does not necessarily have a causal relationship with the treatment.
A TEAE was defined as any AE which on or after exposure to study treatment.
Treatment related TEAEs were TEAEs that were related to study drug and relatedness was judged by investigator.
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Up to Week 37
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Number of Participants With TEAEs and Treatment-Related TEAEs by Severity: Part A
Tidsramme: Up to Week 37
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An AE was defined as any untoward medical occurrence in participant administered an investigational product and which does not necessarily have causal relationship with treatment.
A TEAE was defined as any AE which on or after exposure to study treatment up to 28 days following the last dose.
Treatment related TEAEs were TEAEs that were related to study drug and relatedness was judged by investigator.
Severity: mild: asymptomatic/ mild symptoms, clinical/ diagnostic observations only, intervention not indicated; moderate: minimal, local/ non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily living and severe: medically significant but not immediately life-threatening, hospitalization/ prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living/ life-threatening consequences, urgent intervention indicated/ death related to an AE.
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Up to Week 37
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Number of Participants With Abnormal Clinically Significant Physical Examination: Part A
Tidsramme: From Day 1 of dosing up to post treatment follow up for Part A
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The physical examination included examination of the following body systems (at minimum): head and neck (including complete thyroid exam), cardiovascular, respiratory, gastrointestinal, brief neurological, and general appearance.
Clinical significance will be judged by investigator.
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From Day 1 of dosing up to post treatment follow up for Part A
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Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: Part A
Tidsramme: From Day 1 of dosing up to post treatment follow up for Part A
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Twelve lead ECGs were measured with the participant in a supine position after at least 5 minutes.
Clinical significance will be judged by investigator.
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From Day 1 of dosing up to post treatment follow up for Part A
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Number of Participants With Potential Clinically Significant Laboratory Values: Part A
Tidsramme: From Day 1 of dosing up to post treatment follow up for Part A
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Laboratory parameters assessed included alanine aminotransferase (ALT) (units per liter [U/L]): greater than (>) 1*upper limit of normal (ULN), >3*ULN and >5*ULN; alkaline phosphatase (ALP) (U/L): >2*ULN; amylase (U/L): >1*ULN and >3*ULN; aspartate aminotransferase (AST): >1*ULN, >3*ULN and >5*ULN; estimated glomerular filtration rate (eGFR) (Ckd-Epi [chronic kidney disease epidemiology collaboration]) (milliliter per minute per 1.73m^2): less than (<) 60 mL/min/1.73m^2,
60-90 mL/min/1.73m^2
and >90 mL/min/1.73m^2;
Lipase: >1*ULN and >3*ULN; neutrophils: <1.5, <0.5, 0.5 to <1, 1 to <1.5 and total bilirubin (milligrams per deciliter): >2* upper limit of normal (ULN).
Potential clinical significance was judged by investigator.
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From Day 1 of dosing up to post treatment follow up for Part A
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Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Categories: Part A
Tidsramme: From Day 1 of dosing up to post treatment follow up for Part A
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The C-SSRS is a questionnaire designed for the assessment of suicidal ideation and behavior in adolescents and adults.
C-SSRS were evaluated through category 1 to 10. Suicidal ideation score was defined as the maximum suicidal ideation category (i.e., category 1-5), with 0 assigned if no ideation was present.
Suicidal ideation, defined as 'Yes' if 'Yes' was present in any of category 1-5 and suicidal behavior, defined as 'Yes' if 'Yes' was present in any of category 6-10 and suicidal ideation or behavior, defined as 'Yes' if 'Yes' was present in any of Category 1-10.
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From Day 1 of dosing up to post treatment follow up for Part A
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Patient Health Questionnaire-9 (PHQ-9) Total Score: Part A
Tidsramme: From Day 1 of dosing up to post treatment follow up for Part A
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The PHQ-9 is a questionnaire designed to monitor and measure the severity of depression in participants.
The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead".
Each item was scored on scale of "0=not at all", "several days", "more than half the days" to "nearly every day".
The total score ranges from 0 to 27 by adding score for each question (total points) where: Score 1-4: minimal depression; Score 5-9: Mild depression; Score 10-14: moderate depression; Score 15-19 moderately severe depression; Score 20-27: Severe depression.
Higher score indicates greater severity of depression.
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From Day 1 of dosing up to post treatment follow up for Part A
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Number of Participants With Anti Drug Antibodies (ADAs): Part A
Tidsramme: From Day 1 of dosing up to post treatment follow up for Part A
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Number of participants with baseline, positive and negative ADAs are reported in this outcome measure.
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From Day 1 of dosing up to post treatment follow up for Part A
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Minimum Observed Concentration (Cmin) of Berobenatide: Part A
Tidsramme: From pre-dose on Day 1 up to 168 hours post-dose
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From pre-dose on Day 1 up to 168 hours post-dose
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Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of Berobenatide: Part A
Tidsramme: From pre-dose on Day 1 up to 168 hours post-dose
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AUCtau was area under the concentration versus time curve during the dosing interval (tau), where, tau=168 hours.
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From pre-dose on Day 1 up to 168 hours post-dose
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Maximum Observed Concentration (Cmax) of Berobenatide: Part A
Tidsramme: From pre-dose on Day 1 up to 168 hours post-dose
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Cmax was observed directly from data.
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From pre-dose on Day 1 up to 168 hours post-dose
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Time to Maximum Concentration (Tmax) of Berobenatide: Part A
Tidsramme: From pre-dose on Day 1 up to 168 hours post-dose
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From pre-dose on Day 1 up to 168 hours post-dose
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Plasma Concentration of Berobenatide: Part A
Tidsramme: From pre-dose on Day 1 up to 168 hours post-dose
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From pre-dose on Day 1 up to 168 hours post-dose
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Percent Change From Baseline in Body Weight: Part B
Tidsramme: Baseline (last available measurement prior to first dose received in Part A), End of study
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Baseline (last available measurement prior to first dose received in Part A), End of study
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Number of Participants With TEAEs: Part B
Tidsramme: From Day 1 of dosing in Part B up to 28 days after last dose for Part B
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An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which does not necessarily have a causal relationship with the treatment.
A TEAE was defined as any AE which on or after exposure to study treatment up to 28 days following the last dose.
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From Day 1 of dosing in Part B up to 28 days after last dose for Part B
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
9. oktober 2024
Primær fullføring (Faktiske)
3. juli 2025
Studiet fullført (Faktiske)
30. april 2026
Datoer for studieregistrering
Først innsendt
27. november 2024
Først innsendt som oppfylte QC-kriteriene
27. november 2024
Først lagt ut (Faktiske)
2. desember 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VESPER-1 (MET097-24-201)
- C6491004 (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
produkt produsert i og eksportert fra USA
Nei
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