Een 16 weken durende fase 2b-studie om de veiligheid en werkzaamheid van vier verschillende regimes van wekelijkse MET-097 te onderzoeken (VESPER-1)
6 augustus 2026 bijgewerkt door: Pfizer
Een fase 2b, multicenter, gerandomiseerde, placebogecontroleerde dubbelblinde studie om de veiligheid en werkzaamheid te onderzoeken van 16 weken van vier verschillende regimes van eenmaal per week MET097 bij deelnemers met obesitas en overgewicht
Deze studie is bedoeld om te testen hoe goed MET097, een actief medicijn, werkt bij de behandeling van personen met obesitas of overgewicht in vergelijking met placebo.
MET097 of placebo wordt gedurende 16 weken wekelijks aan personen gegeven.
Als een persoon wordt toegewezen aan MET097, krijgt hij of zij één van de vier verschillende dosisniveaus.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Dit is een multicenter, gerandomiseerde, dubbelblinde, placebogecontroleerde studie om de werkzaamheid en veiligheid van vier verschillende dosisniveaus van MET097 versus placebo te onderzoeken voor gewichtsverlies bij volwassen deelnemers met obesitas of overgewicht (body mass index [BMI ] 27 tot 50 kg/m2, in de leeftijd van 18 tot 70 jaar), met 16 doses van eenmaal per week.
Om veiligheidsredenen worden alle deelnemers gedurende 11 weken (~5 halfwaardetijden) gevolgd na toediening van de laatste wekelijkse dosis.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
239
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Anaheim, California, Verenigde Staten, 92801
- Anaheim Clinical Trials, LLC
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Florida
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Hollywood, Florida, Verenigde Staten, 92801
- Research Centers of America
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusiecriteria:
Body mass index (BMI) bij screening van:
- BMI ≥30 kg/m2 en ≤50,0 kg/m2 (kan de hieronder vermelde gewichtsgerelateerde comorbiditeiten hebben)
BMI ≥27,0 kg/m2 tot <30,0 kg/m2 met ten minste één van de volgende gewichtsgerelateerde comorbiditeiten:
- Hypertensie: wanneer u bloeddrukverlagende medicijnen gebruikt of een systolische bloeddruk ≥130 mmHg of een diastolische bloeddruk ≥80 mmHg heeft bij screening
- Dyslipidemie: als u lipidenverlagende medicatie gebruikt of als u lipoproteïne-cholesterol met lage dichtheid (LDL-C) ≥160 mg/dl (4,1 mmol/l) of triglyceriden ≥150 mg/dl (1,7 mmol/l) heeft, of lipoproteïne-cholesterol met hoge dichtheid cholesterol (HDL-C) <40 mg/dl (1,0 mmol/l) voor mannen of HDL-C <50 mg/dl (1,3 mmol/l) voor vrouwen bij screening
Stabiel lichaamsgewicht (toename of afname ≤5 kg) binnen 3 maanden voorafgaand aan de screening
Uitsluitingscriteria:
- Diagnose van diabetes (T1DM of T2DM) of geglyceerd hemoglobine A1c (HbA1c) ≥ 6,5% of nuchtere plasmaglucose >125 mg/dl.
- Geschatte glomerulaire filtratiesnelheid (eGFR) <75 ml/min/1,73 m2
- Geschiedenis van pancreatitis
- Familie- of persoonlijke voorgeschiedenis van medullair schildkliercarcinoom (MTC) of multipel endocriene neoplasiesyndroom type 2 (MEN-2)
- Voorgeschiedenis van een significante actieve of instabiele depressieve stoornis (MDD) of andere ernstige psychiatrische stoornis in de afgelopen twee jaar
- Elke levensgeschiedenis van een zelfmoordpoging.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo
Tijdens het onderzoek zal een steriele zoutoplossing van 0,9% (w/v) worden gebruikt als placebobehandeling.
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Tijdens het onderzoek zal een steriele zoutoplossing van 0,9% (w/v) worden gebruikt als placebobehandeling.
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Experimenteel: MET097 Actief
MET097 zal eenmaal per week subcutaan worden toegediend in vier verschillende dosisniveaus, zonder titratie.
De verlengingsfase omvat doseringsschema's die minder frequent zijn dan wekelijks.
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MET097 is een ultralangwerkende, volledig bevooroordeelde analoog van menselijk GLP-1.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percent Change From Baseline in Body Weight at Week 28: Part A
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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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
Tijdsspanne: 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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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Pfizer CT.gov Call Center, Pfizer
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
9 oktober 2024
Primaire voltooiing (Werkelijk)
3 juli 2025
Studie voltooiing (Werkelijk)
30 april 2026
Studieregistratiedata
Eerst ingediend
27 november 2024
Eerst ingediend dat voldeed aan de QC-criteria
27 november 2024
Eerst geplaatst (Werkelijk)
2 december 2024
Updates van studierecords
Laatste update geplaatst (Werkelijk)
28 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
6 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- VESPER-1 (MET097-24-201)
- C6491004 (Andere identificatie: Alias Study Number)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .