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Zealand PharmaEfficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06926842 untersucht Behandlung im Zusammenhang mit Übergewicht, Typ-2-Diabetes, Fettleibigkeit. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 22. April 2025. Es ist geplant, 216 Teilnehmer aufzunehmen. Durchgeführt von Zealand Pharma wird der Abschluss für 13. August 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 28. Oktober 2025 aktualisiert.
Kurzbeschreibung
The main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.
Offizieller Titel
A Randomized, Double-Blind, Phase 2 Trial of Once-Weekly Petrelintide Compared With Placebo in Participants With Overweight or Obesity and Type 2 Diabetes
Erkrankungen
ÜbergewichtTyp-2-DiabetesFettleibigkeitWeitere Studien-IDs
- ZP8396-24115
NCT-Nummer
Studienbeginn (tatsächlich)
2025-04-22
Zuletzt aktualisiert
2025-10-28
Studienende (vorauss.)
2026-08-13
Geplante Rekrutierung
216
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Offene Rekrutierung
Stichwörter
Long-acting amylin analogues
Weight management
Weight management
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellTreatment A: Petrelintide Dose 1 Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 1. | Petrelintide Petrelintide will be taken by participants once weekly subcutaneously. |
Placebo-VergleichspräparatTreatment B: Petrelintide Placebo Dose 1 Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide. | PLACEBO Matching placebo to petrelintide will be taken by participants once weekly subcutaneously. |
ExperimentellTreatment C: Petrelintide Dose 2 Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 2. | Petrelintide Petrelintide will be taken by participants once weekly subcutaneously. |
Placebo-VergleichspräparatTreatment D: Petrelintide Placebo Dose 2 Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide. | PLACEBO Matching placebo to petrelintide will be taken by participants once weekly subcutaneously. |
ExperimentellTreatment E: Petrelintide Dose 3 Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 3. | Petrelintide Petrelintide will be taken by participants once weekly subcutaneously. |
Placebo-VergleichspräparatTreatment F: Petrelintide Placebo Dose 3 Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide. | PLACEBO Matching placebo to petrelintide will be taken by participants once weekly subcutaneously. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Percentage Change in Body Weight | From Baseline (Day 1) to Weeks 28 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Number of Participants Achieving ≥5% Body Weight Loss | From Baseline (Day 1) to Weeks 28 | |
Number of Participants Achieving ≥10% Body Weight Loss | From Baseline (Day 1) to Weeks 28 | |
Change in Body Weight (kilogram) | From Baseline (Day 1) to Weeks 28 | |
Change in Waist Circumference | From Baseline (Day 1) to Weeks 28 | |
Change in Glycated Hemoglobin (HbA1c) | From Baseline (Day 1) to Weeks 28 | |
Change in Fasting Glucose | From Baseline (Day 1) to Weeks 28 | |
Change in High-Sensitivity C-reactive protein (hsCRP) | From Baseline (Day 1) to Weeks 28 | |
Number of Participants Achieving <7% HbA1c | From Baseline (Day 1) to Weeks 28 | |
Number of Participants Achieving ≤6.5% HbA1c | From Baseline (Day 1) to Weeks 28 | |
Changes in Fasting Lipids | From Baseline (Day 1) to Weeks 28 | |
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From Baseline (Day 1) to Weeks 38 | |
Number of Participants with Treatment- Emergent Severe or Clinically Significant Hypoglycemic Episodes from Baseline to Week 38 | From Baseline (Day 1) to Weeks 38 | |
Number of Participants with Positive Anti-Drug Antibodies (ADAs) | From Baseline (Day 1) to Weeks 38 | |
Change in Systolic Blood Pressure | From Baseline (Day 1) to Week 38 | |
Change in Diastolic Blood Pressure | From Baseline (Day 1) to Week 38 | |
Change in Pulse Rate | From Baseline (Day 1) to Week 38 |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Male or female participants with body mass index (BMI) ≥27.0 kg/m2.
- Diagnosed with type 2 diabetes ≥180 days prior to the day of screening.
- Treated with metformin with or without sodium-glucose cotransporter 2 inhibitors. Treatment should be stable (same drug[s], dose, and dosing frequency) for at least 90 days prior to screening.
- Severe hypoglycemia within 6 months prior to screening or history of hypoglycemia unawareness.
- Receipt of any other glucose-lowering drug than those listed in the inclusion criterion within 90 days prior to screening.
- A self-reported change in body weight >5% within 90 days prior to screening, irrespective of medical records.
- Treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 6 months prior to screening.
- Previous or planned (during the trial period) obesity treatment with surgery or a body weight loss device. However, liposuction or surgical removal of fat depots more than 1 year prior to screening or device-based interventions (e.g., sleeve, banding, or similar) that have been removed more than 6 months prior to screening, are allowed.
- Obesity due to endocrine disorders or genetic syndromes.
Zealand Pharma11 aktive klinische Studien zum ErkundenParexelZentrale Studienkontakte
Kontakt: Zealand Pharma, +45 8877 3600, [email protected]
49 Studienstandorte in 1 Ländern
Alabama
Cullman Clinical Trials - Family Medicine, Cullman, Alabama, 35055, United States
Offene Rekrutierung
Arizona
AZ Endocrine Institute, Chandler, Arizona, 85224, United States
Offene Rekrutierung
Elite Clinical Studies, LLC, Phoenix, Arizona, 85018, United States
Offene Rekrutierung
M3 Wake Research, Tucson Neuroscience Research, LLC, Tucson, Arizona, 85710, United States
Offene Rekrutierung
Arkansas
Medical Investigation Inc, Little Rock, Arkansas, 72211-1847, United States
Offene Rekrutierung
California
AMCR Institute, Inc., Escondido, California, 92025, United States
Zurückgezogen
Velocity Clinical Research, Huntington Park, California, 90255, United States
Offene Rekrutierung
Velocity Clinical Research, North Hollywood, North Hollywood, California, 91606, United States
Offene Rekrutierung
Exalt Clinical Research, San Diego, California, 91910, United States
Offene Rekrutierung
Diablo Clinical Research Inc., Walnut Creek, California, 94598, United States
Offene Rekrutierung
Connecticut
Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States
Offene Rekrutierung
District of Columbia
Emerson Clinical Research, Washington D.C., District of Columbia, 20009, United States
Offene Rekrutierung
Florida
Innovative Research of West Florida, Clearwater, Florida, 33756, United States
Offene Rekrutierung
East Coast Institute for Research, LLC, Jacksonville, Florida, 32204, United States
Offene Rekrutierung
Solutions Through Advanced Research, Inc, Jacksonville, Florida, 32216, United States
Offene Rekrutierung
M3 Wake Research - Lake City, Lake City, Florida, 32055, United States
Offene Rekrutierung
West Orange Endocrinology P.A, Ocoee, Florida, 34761, United States
Offene Rekrutierung
Palm Beach Research Center, West Palm Beach, Florida, 33409, United States
Offene Rekrutierung
Georgia
M3 Wake Research - Atlanta, Atlanta, Georgia, 30328, United States
Offene Rekrutierung
East Coast Institute for Research - Canton, Canton, Georgia, 30114, United States
Offene Rekrutierung
Privia Medical Group Georgia, LLC, Savannah, Georgia, 31406, United States
Offene Rekrutierung
Illinois
Great Lakes Clinical Trials, Chicago, Illinois, 60640, United States
Offene Rekrutierung
Iowa
Iowa Diabetes & Endocrinology Research Center, West Des Moines, Iowa, 50266, United States
Offene Rekrutierung
Kansas
Heartland Research Associates, LLC, Wichita, Kansas, 67207, United States
Offene Rekrutierung
Louisiana
DelRicht Research - New Orleans, New Orleans, Louisiana, 70115, United States
Offene Rekrutierung
Michigan
AAMRC, Flint, Michigan, 48504, United States
Offene Rekrutierung
Minnesota
International Diabetes Center, Minneapolis, Minnesota, 55416, United States
Offene Rekrutierung
Mississippi
Velocity Clinical Research, Gulfport, Gulfport, Mississippi, 39503, United States
Offene Rekrutierung
Missouri
AMR Kansas City, Kansas City, Missouri, 64114, United States
Offene Rekrutierung
Montana
Mercury Street Medical Group, PLLC, Butte, Montana, 59701, United States
Offene Rekrutierung
Nevada
M3 Wake Research - Las Vegas, NV, Las Vegas, Nevada, 89106, United States
Offene Rekrutierung
Palm Research Center, Inc., Las Vegas, Nevada, 89148, United States
Offene Rekrutierung
North Carolina
Javara Inc, Charlotte, North Carolina, 28210, United States
Offene Rekrutierung
PharmQuest Life Sciences, LLC, Greensboro, North Carolina, 27408, United States
Offene Rekrutierung
M3 Wake Research, Raleigh, North Carolina, 27612, United States
Offene Rekrutierung
Ohio
Velocity Clinical Research, Cincinnati, Mt. Auburn, Cincinnati, Ohio, 45219, United States
Offene Rekrutierung
Centricity Research, Columbus, Ohio, 43213, United States
Offene Rekrutierung
Oklahoma
Lynn Institute of Norman, Norman, Oklahoma, 73072, United States
Offene Rekrutierung
South Carolina
M3 Wake Research - Charleston, Charleston, South Carolina, 29414, United States
Offene Rekrutierung
Tennessee
M3 Wake Research/ClinSearch, LLC, Chattanooga, Tennessee, 37421, United States
Offene Rekrutierung
Texas
Elligo Clinical Research, Inc., Austin, Texas, 78704, United States
Offene Rekrutierung
The University of Texas Southwestern Medical Center, Dallas, Texas, 75390-8857, United States
Offene Rekrutierung
Juno Research LLC, Houston, Texas, 77040, United States
Offene Rekrutierung
Tekton Research, LLC, Irving, Texas, 75039, United States
Offene Rekrutierung
Tekton Research, LLC, McKinney, Texas, 75069, United States
Offene Rekrutierung
Texas Health Care, PLLC, San Marcos, Texas, 78666, United States
Offene Rekrutierung
Consano Clinical Research, Shavano Park, Texas, 78231, United States
Offene Rekrutierung
Texas Health Care, Stephenville, Texas, 76401, United States
Offene Rekrutierung
Virginia
Manaasas Clinical Research Center, Manassas, Virginia, 20110, United States
Offene Rekrutierung