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Uno studio di Fase 2b di 16 settimane per esaminare la sicurezza e l'efficacia di quattro diversi regimi di MET-097 una volta alla settimana (VESPER-1)

6 agosto 2026 aggiornato da: Pfizer

Uno studio di fase 2b, multicentrico, randomizzato, controllato con placebo, in doppio cieco per indagare la sicurezza e l'efficacia di 16 settimane di quattro diversi regimi di MET097 una volta alla settimana in partecipanti con obesità e sovrappeso

Questo studio è progettato per testare l'efficacia di MET097, un farmaco attivo, nel trattamento di soggetti obesi o sovrappeso rispetto al placebo. MET097 o placebo verranno somministrati agli individui settimanalmente per 16 settimane. Se un individuo viene assegnato a MET097 riceverà uno dei quattro diversi livelli di dose.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Si tratta di uno studio multicentrico, randomizzato, in doppio cieco, controllato con placebo volto a valutare l'efficacia e la sicurezza di quattro diversi livelli di dosaggio di MET097 rispetto al placebo per la perdita di peso corporeo in partecipanti adulti con obesità o sovrappeso (indice di massa corporea [BMI ] da 27 a 50 kg/m2, di età compresa tra 18 e 70 anni), con 16 dosi da somministrare una volta alla settimana. Tutti i partecipanti saranno seguiti per 11 settimane (~ 5 emivite) dopo la somministrazione dell'ultima dose settimanale per motivi di sicurezza.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

239

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • Anaheim, California, Stati Uniti, 92801
        • Anaheim Clinical Trials, LLC
    • Florida
      • Hollywood, Florida, Stati Uniti, 92801
        • Research Centers of America

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Criteri di inclusione:

  • Indice di massa corporea (BMI) allo screening di:

    • BMI ≥30 kg/m2 e ≤50,0 kg/m2 (possono presentare le comorbilità legate al peso elencate di seguito)

    • BMI da ≥27,0 kg/m2 a <30,0 kg/m2 con almeno una delle seguenti comorbilità legate al peso:

      1. Ipertensione: in terapia con farmaci che abbassano la pressione sanguigna o con pressione sistolica ≥ 130 mmHg o pressione diastolica ≥ 80 mmHg allo screening
      2. Dislipidemia: in terapia con farmaci ipolipemizzanti o con colesterolo lipoproteico a bassa densità (LDL-C) ≥ 160 mg/dL (4,1 mmol/L) o trigliceridi ≥ 150 mg/dL (1,7 mmol/L) o lipoproteine ​​ad alta densità colesterolo (HDL-C) <40 mg/dL (1,0 mmol/L) per gli uomini o HDL-C <50 mg/dL (1,3 mmol/L) per le donne allo screening

Peso corporeo stabile (aumento o diminuzione ≤5 kg) entro 3 mesi prima dello screening

Criteri di esclusione:

  • Diagnosi di diabete (T1DM o T2DM) o emoglobina glicata A1c (HbA1c) ≥ 6,5% o glicemia a digiuno > 125 mg/dl.
  • Velocità di filtrazione glomerulare stimata (eGFR) <75 ml/min/1,73 m2
  • Storia di pancreatite
  • Storia familiare o personale di carcinoma midollare della tiroide (MTC) o sindrome da neoplasia endocrina multipla di tipo 2 (MEN-2)
  • Storia di disturbo depressivo maggiore (MDD) attivo o instabile significativo o altro disturbo psichiatrico grave negli ultimi 2 anni
  • Qualsiasi storia di tentativi di suicidio nella vita.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Durante lo studio verrà utilizzata una soluzione salina sterile allo 0,9% (p/v) come trattamento placebo.
Droga: Placebo
Durante lo studio verrà utilizzata una soluzione salina sterile allo 0,9% (p/v) come trattamento placebo.
Sperimentale: MET097 Attivo
MET097 sarà somministrato a quattro diversi livelli di dose per via sottocutanea una volta alla settimana senza titolazione. La fase di estensione prevede regimi di dosaggio meno frequenti di quelli settimanali.
Droga: MET097
MET097 è un analogo completamente distorto e ad azione ultra prolungata del GLP-1 umano.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent Change From Baseline in Body Weight at Week 28: Part A
Lasso di tempo: Baseline (last non-missing measurement prior to the first dose), Week 28
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.
Baseline (last non-missing measurement prior to the first dose), Week 28

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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.
Baseline, Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169
Number of Participants With Reduction in Body Weight Greater Than or Equal to (>=) 5 Percent (%) From Baseline at Week 28: Part A
Lasso di tempo: Baseline, Week 28
Baseline, Week 28
Number of Participants With Reduction in Body Weight >= 10 % From Baseline at Week 28: Part A
Lasso di tempo: Baseline, Week 28
Baseline, Week 28
Number of Participants With Reduction in Body Weight >= 15 % From Baseline at Week 28: Part A
Lasso di tempo: Baseline, Week 28
Baseline, Week 28
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
Lasso di tempo: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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
Lasso di tempo: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
BMI was derived from body weight in kilograms (kg) and height in meters (m), and it was calculated as weight divided by height^2.
Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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
Lasso di tempo: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
Number of Participants With Gastrointestinal (GI) Adverse Event of Clinical Interest (AECI): Part A
Lasso di tempo: From Day 1 of dosing up to 28 days after last dose for Part A
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.
From Day 1 of dosing up to 28 days after last dose for Part A
Number of Participants With Treatment Related Gastrointestinal AECIs: Part A
Lasso di tempo: From Day 1 of dosing up to 28 days after last dose for Part A
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.
From Day 1 of dosing up to 28 days after last dose for Part A
Number of Participants With Gastrointestinal AECI and Treatment Related AECIs by Severity: Part A
Lasso di tempo: From Day 1 of dosing up to 28 days after last dose for Part A
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.
From Day 1 of dosing up to 28 days after last dose for Part A
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs: Part A
Lasso di tempo: Up to Week 37
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.
Up to Week 37
Number of Participants With TEAEs and Treatment-Related TEAEs by Severity: Part A
Lasso di tempo: Up to Week 37
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.
Up to Week 37
Number of Participants With Abnormal Clinically Significant Physical Examination: Part A
Lasso di tempo: From Day 1 of dosing up to post treatment follow up for Part A
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.
From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: Part A
Lasso di tempo: From Day 1 of dosing up to post treatment follow up for Part A
Twelve lead ECGs were measured with the participant in a supine position after at least 5 minutes. Clinical significance will be judged by investigator.
From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants With Potential Clinically Significant Laboratory Values: Part A
Lasso di tempo: From Day 1 of dosing up to post treatment follow up for Part A
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.
From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Categories: Part A
Lasso di tempo: From Day 1 of dosing up to post treatment follow up for Part A
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.
From Day 1 of dosing up to post treatment follow up for Part A
Patient Health Questionnaire-9 (PHQ-9) Total Score: Part A
Lasso di tempo: From Day 1 of dosing up to post treatment follow up for Part A
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.
From Day 1 of dosing up to post treatment follow up for Part A
Number of Participants With Anti Drug Antibodies (ADAs): Part A
Lasso di tempo: From Day 1 of dosing up to post treatment follow up for Part A
Number of participants with baseline, positive and negative ADAs are reported in this outcome measure.
From Day 1 of dosing up to post treatment follow up for Part A
Minimum Observed Concentration (Cmin) of Berobenatide: Part A
Lasso di tempo: From pre-dose on Day 1 up to 168 hours post-dose
From pre-dose on Day 1 up to 168 hours post-dose
Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of Berobenatide: Part A
Lasso di tempo: From pre-dose on Day 1 up to 168 hours post-dose
AUCtau was area under the concentration versus time curve during the dosing interval (tau), where, tau=168 hours.
From pre-dose on Day 1 up to 168 hours post-dose
Maximum Observed Concentration (Cmax) of Berobenatide: Part A
Lasso di tempo: From pre-dose on Day 1 up to 168 hours post-dose
Cmax was observed directly from data.
From pre-dose on Day 1 up to 168 hours post-dose
Time to Maximum Concentration (Tmax) of Berobenatide: Part A
Lasso di tempo: From pre-dose on Day 1 up to 168 hours post-dose
From pre-dose on Day 1 up to 168 hours post-dose
Plasma Concentration of Berobenatide: Part A
Lasso di tempo: From pre-dose on Day 1 up to 168 hours post-dose
From pre-dose on Day 1 up to 168 hours post-dose
Percent Change From Baseline in Body Weight: Part B
Lasso di tempo: Baseline (last available measurement prior to first dose received in Part A), End of study
Baseline (last available measurement prior to first dose received in Part A), End of study
Number of Participants With TEAEs: Part B
Lasso di tempo: From Day 1 of dosing in Part B up to 28 days after last dose for Part B
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.
From Day 1 of dosing in Part B up to 28 days after last dose for Part B

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Investigatori

  • Direttore dello studio: Pfizer CT.gov Call Center, Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 ottobre 2024

Completamento primario (Effettivo)

3 luglio 2025

Completamento dello studio (Effettivo)

30 aprile 2026

Date di iscrizione allo studio

Primo inviato

27 novembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

27 novembre 2024

Primo Inserito (Effettivo)

2 dicembre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • VESPER-1 (MET097-24-201)
  • C6491004 (Altro identificatore: Alias Study Number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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