Eine 16-wöchige Phase-2b-Studie zur Untersuchung der Sicherheit und Wirksamkeit von vier verschiedenen Behandlungsschemata mit einmal wöchentlicher MET-097-Therapie (VESPER-1)
6. August 2026 aktualisiert von: Pfizer
Eine multizentrische, randomisierte, placebokontrollierte Doppelblindstudie der Phase 2b zur Untersuchung der Sicherheit und Wirksamkeit von 16 Wochen mit vier verschiedenen Behandlungsschemata von einmal wöchentlich MET097 bei Teilnehmern mit Fettleibigkeit und Übergewicht
Diese Studie soll testen, wie gut MET097, ein Wirkstoff, bei der Behandlung von Personen mit Fettleibigkeit oder Übergewicht im Vergleich zu Placebo wirkt.
MET097 oder Placebo werden den einzelnen Personen 16 Wochen lang wöchentlich verabreicht.
Wenn eine Person MET097 zugewiesen wird, erhält sie eine von vier verschiedenen Dosisstufen.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Hierbei handelt es sich um eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Studie zur Untersuchung der Wirksamkeit und Sicherheit von vier verschiedenen Dosierungen von MET097 im Vergleich zu Placebo zur Körpergewichtsabnahme bei erwachsenen Teilnehmern mit Adipositas oder Übergewicht (Body-Mass-Index [BMI]). ] 27 bis 50 kg/m2, im Alter von 18 bis 70 Jahren), mit 16 Dosen einmal wöchentlich.
Alle Teilnehmer werden aus Sicherheitsgründen 11 Wochen lang (~5 Halbwertszeiten) nach Verabreichung der letzten wöchentlichen Dosis beobachtet.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
239
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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California
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Anaheim, California, Vereinigte Staaten, 92801
- Anaheim Clinical Trials, LLC
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Florida
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Hollywood, Florida, Vereinigte Staaten, 92801
- Research Centers of America
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Einschlusskriterien:
Body-Mass-Index (BMI) beim Screening von:
- BMI ≥30 kg/m2 und ≤50,0 kg/m2 (kann die unten aufgeführten gewichtsbedingten Komorbiditäten haben)
BMI ≥27,0 kg/m2 bis <30,0 kg/m2 mit mindestens einer der folgenden gewichtsbedingten Komorbiditäten:
- Hypertonie: Einnahme von blutdrucksenkenden Medikamenten oder systolischer Blutdruck ≥ 130 mmHg oder diastolischer Blutdruck ≥ 80 mmHg beim Screening
- Dyslipidämie: Sie nehmen lipidsenkende Medikamente ein oder haben Low-Density-Lipoprotein-Cholesterin (LDL-C) ≥160 mg/dL (4,1 mmol/L) oder Triglyceride ≥150 mg/dL (1,7 mmol/L) oder High-Density-Lipoprotein-Cholesterin. Cholesterin (HDL-C) <40 mg/dL (1,0 mmol/L) für Männer oder HDL-C <50 mg/dL (1,3 mmol/L) für Frauen beim Screening
Stabiles Körpergewicht (Zunahme oder Abnahme ≤5 kg) innerhalb von 3 Monaten vor dem Screening
Ausschlusskriterien:
- Diagnose von Diabetes (T1DM oder T2DM) oder glykiertem Hämoglobin A1c (HbA1c) ≥ 6,5 % oder Nüchternplasmaglukose > 125 mg/dl.
- Geschätzte glomeruläre Filtrationsrate (eGFR) <75 ml/min/1,73 m2
- Vorgeschichte einer Pankreatitis
- Familiäre oder persönliche Vorgeschichte von medullärem Schilddrüsenkarzinom (MTC) oder multiplem endokrinen Neoplasie-Syndrom Typ 2 (MEN-2)
- Vorgeschichte einer signifikanten aktiven oder instabilen schweren depressiven Störung (MDD) oder einer anderen schweren psychiatrischen Störung innerhalb der letzten 2 Jahre
- Jede lebenslange Vorgeschichte eines Selbstmordversuchs.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Placebo-Komparator: Placebo
Während der Studie wird sterile 0,9 %ige (w/v) Kochsalzlösung als Placebo-Behandlung verwendet.
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Während der Studie wird sterile 0,9 %ige (w/v) Kochsalzlösung als Placebo-Behandlung verwendet.
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Experimental: MET097 Aktiv
MET097 wird einmal wöchentlich ohne Titration in vier verschiedenen Dosierungen subkutan verabreicht.
Die Verlängerungsphase umfasst Dosierungsschemata, die weniger häufig als wöchentlich erfolgen.
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MET097 ist ein extrem lang wirkendes, vollständig wirksames Analogon von menschlichem GLP-1.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percent Change From Baseline in Body Weight at Week 28: Part A
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Pfizer CT.gov Call Center, Pfizer
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
9. Oktober 2024
Primärer Abschluss (Tatsächlich)
3. Juli 2025
Studienabschluss (Tatsächlich)
30. April 2026
Studienanmeldedaten
Zuerst eingereicht
27. November 2024
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. November 2024
Zuerst gepostet (Tatsächlich)
2. Dezember 2024
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- VESPER-1 (MET097-24-201)
- C6491004 (Andere Kennung: Alias Study Number)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .