Effekt og sikkerhed ved KAI-9531 administreret en gang ugentligt hos deltagere med overvægt eller fedme og diabetes (KaiNETIC-2)
5. oktober 2026 opdateret af: Kailera
En fase 3, randomiseret, dobbeltblind, placebokontrolleret undersøgelse for at vurdere effektiviteten og sikkerheden af KAI-9531 administreret en gang om ugen hos deltagere med fedme eller overvægt og diabetes
The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to placebo on:
- Percent change in body weight
- Change in hemoglobin A1c (HbA1c)
Studieoversigt
Status
Status
Aktiv, ikke rekrutterende
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
1270
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina, 1056
- Kailera Clinical Site #1
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Buenos Aires, Argentina, 1056
- Kailera Clinical Site #2
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Buenos Aires, Argentina, 1060
- Kailera Clinical Site
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Buenos Aires, Argentina, 1061
- Kailera Clinical Site
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Buenos Aires, Argentina, 1128
- Kailera Clinical Site
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Córdoba, Argentina, 5000
- Kailera Clinical Site
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Córdoba, Argentina, 5002
- Kailera Clinical Site
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1120
- Kailera Clinical Site
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La Plata, Buenos Aires, Argentina, 1900
- Kailera Clinical Site
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Mar del Plata, Buenos Aires, Argentina, 7600
- Kailera Clinical Site
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San Nicolás de los Arroyos, Buenos Aires, Argentina, 2900
- Kailera Clinical Site
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Zárate, Buenos Aires, Argentina, 2800
- Kailera Clinical Site
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Mendoza Province
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Godoy Cruz, Mendoza Province, Argentina, 5501
- Kailera Clinical Site
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Kailera Clinical Site #1
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Rosario, Santa Fe Province, Argentina, 2000
- Kailera Clinical Site #2
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Rosario, Santa Fe Province, Argentina, 2000
- Kailera Clinical Site #3
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Sante Fe
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Rosario, Sante Fe, Argentina, 2000
- Kailera Clinical Site #4
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South Brisbane, Australien, 4101
- Kailera Clinical Site
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Australian Capital Territory
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Bruce, Australian Capital Territory, Australien, 2617
- Kailera Clinical Site
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New South Wales
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Blacktown, New South Wales, Australien, 2148
- Kailera Clinical Site
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Charlestown, New South Wales, Australien, 2290
- Kailera Clinical Site
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Kanwal, New South Wales, Australien, 2259
- Kailera Clinical Site
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Leichhardt, New South Wales, Australien, 2040
- Kailera Clinical Site
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Penrith, New South Wales, Australien, 2750
- Kailera Clinical Site
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Sydney, New South Wales, Australien, 2100
- Kailera Clinical Site
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Sydney, New South Wales, Australien, 2228
- Kailera Clinical Site
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Wollongong, New South Wales, Australien, 2500
- Kailera Clinical Site
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Queensland
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Herston, Queensland, Australien, 4006
- Kailera Clinical Site
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Morayfield, Queensland, Australien, 4506
- Kailera Clinical Site
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Victoria
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Camberwell, Victoria, Australien, 3124
- Kailera Clinical Site
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Melbourne, Victoria, Australien, 3025
- Kailera Clinical Site
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Montana, Bulgarien, 3400
- Kailera Clinical Site
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Kyustendil Province
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Kyustendil, Kyustendil Province, Bulgarien, 2500
- Kailera Clinical Site
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Pleven Province
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Pleven, Pleven Province, Bulgarien, 5800
- Kailera Clinical Site
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Plovdiv Province
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Plovdiv, Plovdiv Province, Bulgarien, 4020
- Kailera Clinical Site
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Ruse Province
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Rousse, Ruse Province, Bulgarien, 7013
- Kailera Clinical Site
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Sofia
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Sofia, Sofia, Bulgarien, 1527
- Kailera Clinical Site
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Sofia, Sofia, Bulgarien, 1606
- Kailera Clinical Site
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Sofia, Sofia, Bulgarien, 1618
- Kailera Clinical Site
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Stara Zagora Province
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Stara Zagora, Stara Zagora Province, Bulgarien, 6000
- Kailera Clinical Site
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Varna Province
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Varna, Varna Province, Bulgarien, 9000
- Kailera Clinical Site
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Manchester, Det Forenede Kongerige, M13 9WL
- Kailera Clinical Site
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Cornwall
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Truro, Cornwall, Det Forenede Kongerige, TR1 3LJ
- Kailera Clinical Site
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Devon
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Plymouth, Devon, Det Forenede Kongerige, PL6 8DH
- Kailera Clinical Site
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Dorset
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Bournemouth, Dorset, Det Forenede Kongerige, BH7 7DW
- Kailera Clinical Site
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East Yorkshire
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Hull, East Yorkshire, Det Forenede Kongerige, HU3 2JZ
- Kailera Clinical Site
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Glasgow City
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Glasgow, Glasgow City, Det Forenede Kongerige, G51 4TF
- Kailera Clinical Site
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Greater London
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London, Greater London, Det Forenede Kongerige, EC1M 6BQ
- Kailera Clinical Site
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Hertfordshire
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Stevenage, Hertfordshire, Det Forenede Kongerige, SG1 4AB
- Kailera Clinical Site
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Leicestershire
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Leicester, Leicestershire, Det Forenede Kongerige, LE5 4PW
- Kailera Clinical Site
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Nottinghamshire
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Nottingham, Nottinghamshire, Det Forenede Kongerige, NG7 2QW
- Kailera Clinical Site
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South Gloucestershire
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Yate, South Gloucestershire, Det Forenede Kongerige, BS37 4AX
- Kailera Clinical Site
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Tyne and Wear
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Newcastle upon Tyne, Tyne and Wear, Det Forenede Kongerige, NE1 4LP
- Kailera Clinical Site
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West Yorkshire
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Bradford, West Yorkshire, Det Forenede Kongerige, BD9 6RJ
- Kailera Clinical Site
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Alabama
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Cullman, Alabama, Forenede Stater, 35055
- Kailera Clinical Site
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Arizona
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Phoenix, Arizona, Forenede Stater, 85012
- Kailera Clinical Site
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Sun City, Arizona, Forenede Stater, 85351
- Kailera Clinical Site
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Kailera Clinical Site
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California
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Escondido, California, Forenede Stater, 92025
- Kailera Clinical Site
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La Mesa, California, Forenede Stater, 91942
- Kailera Clinical Site
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Montclair, California, Forenede Stater, 91763
- Kailera Clinical Site
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Northridge, California, Forenede Stater, 91325
- Kailera Clinical Site
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Oceanside, California, Forenede Stater, 92058
- Kailera Clinical Site
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Toluca Lake, California, Forenede Stater, 91602
- Kailera Clinical Site
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Connecticut
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Stamford, Connecticut, Forenede Stater, 06905
- Kailera Clinical Site
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Florida
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Bradenton, Florida, Forenede Stater, 34209
- Kailera Clinical Site
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Hollywood, Florida, Forenede Stater, 33024
- Kailera Clinical Site
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Jupiter, Florida, Forenede Stater, 33458
- Kailera Clinical Site
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Miami, Florida, Forenede Stater, 33135
- Kailera Clinical Site
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Miami Lakes, Florida, Forenede Stater, 33016
- Kailera Clinical Site
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Orange City, Florida, Forenede Stater, 32763
- Kailera Clinical Site
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Orlando, Florida, Forenede Stater, 32801
- Kailera Clinical Site
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Orlando, Florida, Forenede Stater, 32803
- Kailera Clinical Site
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The Villages, Florida, Forenede Stater, 32162
- Kailera Clinical Site
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Georgia
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Decatur, Georgia, Forenede Stater, 30030
- Kailera Clinical Site
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Lilburn, Georgia, Forenede Stater, 30047
- Kailera Clinical Site
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Marietta, Georgia, Forenede Stater, 30060
- Kailera Clinical Site
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Riverdale, Georgia, Forenede Stater, 30274
- Kailera Clinical Site
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Illinois
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Skokie, Illinois, Forenede Stater, 60077
- Kailera Clinical Site
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Springfield, Illinois, Forenede Stater, 62702
- Kailera Clinical Site
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Kansas
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Newton, Kansas, Forenede Stater, 67114
- Kailera Clinical Site
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71105
- Kailera Clinical Site
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- Kailera Clinical Site
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Columbia, Maryland, Forenede Stater, 21045
- Kailera Clinical Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Kailera Clinical Site
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Michigan
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Farmington Hills, Michigan, Forenede Stater, 48334
- Kailera Clinical Site
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Montana
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Missoula, Montana, Forenede Stater, 59804
- Kailera Clinical Site
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68516
- Kailera Clinical Site
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89148
- Kailera Clinical Site
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New York
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Albany, New York, Forenede Stater, 12203
- Kailera Clinical Site
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Laurelton, New York, Forenede Stater, 11413
- Kailera Clinical Site
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New York, New York, Forenede Stater, 10016
- Kailera Clinical Site
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North Carolina
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Greensboro, North Carolina, Forenede Stater, 27405
- Kailera Clinical Site
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Monroe, North Carolina, Forenede Stater, 28112
- Kailera Clinical Site
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Morehead City, North Carolina, Forenede Stater, 28557
- Kailera Clinical Site #1
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Morehead City, North Carolina, Forenede Stater, 28557
- Kailera Clinical Site #2
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Morrisville, North Carolina, Forenede Stater, 27560
- Kailera Clinical Site
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Ohio
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Cleveland, Ohio, Forenede Stater, 44122
- Kailera Clinical Site
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Oklahoma
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Chickasha, Oklahoma, Forenede Stater, 73018
- Kailera Clinical Site
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Rhode Island
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East Greenwich, Rhode Island, Forenede Stater, 02818
- Kailera Clinical Site
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South Carolina
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Spartanburg, South Carolina, Forenede Stater, 29303
- Kailera Clinical Site
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37405
- Kailera Clinical Site
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Memphis, Tennessee, Forenede Stater, 38119
- Kailera Clinical Site
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Texas
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Amarillo, Texas, Forenede Stater, 79124
- Kailera Clinical Site
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Brownsville, Texas, Forenede Stater, 78526
- Kailera Clinical Site
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DeSoto, Texas, Forenede Stater, 75115
- Kailera Clinical Site
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El Paso, Texas, Forenede Stater, 79902
- Kailera Clinical Site
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Farmers Branch, Texas, Forenede Stater, 75234
- Kailera Clinical Site
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Kingwood, Texas, Forenede Stater, 77345
- Kailera Clinical Site
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Plano, Texas, Forenede Stater, 75093
- Kailera Clinical Site
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Tomball, Texas, Forenede Stater, 77375
- Kailera Clinical Site
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Utah
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Pleasant View, Utah, Forenede Stater, 84404
- Kailera Clinical Site
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Salt Lake City, Utah, Forenede Stater, 84117
- Kailera Clinical Site
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Virginia
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Manassas, Virginia, Forenede Stater, 20110
- Kailera Clinical Site
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Richmond, Virginia, Forenede Stater, 23236
- Kailera Clinical Site
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Kailera Clinical Site
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Auckland, New Zealand, 1023
- Kailera Clinical Site
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Hastings, New Zealand, 4120
- Kailera Clinical Site
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Nelson, New Zealand, 7011
- Kailera Clinical Site
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Auckland
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Grafton, Auckland, New Zealand, 1010
- Kailera Clinical Site
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New Lynn, Auckland, New Zealand, 0610
- Kailera Clinical Site
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Silverdale, Auckland, New Zealand, 0932
- Kailera Clinical Site
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Takapuna, Auckland, New Zealand, 0622
- Kailera Clinical Site
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Hamilton
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Nawton, Hamilton, New Zealand, 3200
- Kailera Clinical Site
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Krakow, Polen, 30-363
- Kailera Clinical Site
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Warsaw, Polen, 02-677
- Kailera Clinical Site
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-231
- Kailera Clinical Site
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Torun, Kuyavian-Pomeranian Voivodeship, Polen, 87-100
- Kailera Clinical Site
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 30-033
- Kailera Clinical Site
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polen, 20-718
- Kailera Clinical Site
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Masovian Voivodeship
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Siedlce, Masovian Voivodeship, Polen, 08-110
- Kailera Clinical Site
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Warsaw, Masovian Voivodeship, Polen, 00-872
- Kailera Clinical Site
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polen, 15-351
- Kailera Clinical Site
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Pomeranian Voivodeship
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Gdynia, Pomeranian Voivodeship, Polen, 81-338
- Kailera Clinical Site #1
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Gdynia, Pomeranian Voivodeship, Polen, 81-338
- Kailera Clinical Site #2
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Silesian Voivodeship
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Chorzów, Silesian Voivodeship, Polen, 41-500
- Kailera Clinical Site
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Łódź Voivodeship
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Skierniewice, Łódź Voivodeship, Polen, 96-100
- Kailera Clinical Site
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Świętokrzyskie Voivodeship
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Kielce, Świętokrzyskie Voivodeship, Polen, 25-338
- Kailera Clinical Site
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Bayamón, Puerto Rico, 00959
- Kailera Clinical Site #1
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Bayamón, Puerto Rico, 00959
- Kailera Clinical Site #2
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Ponce, Puerto Rico, 00716
- Kailera Clinical Site
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San Juan, Puerto Rico, 00907
- Kailera Clinical Site
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San Juan, Puerto Rico, 00909
- Kailera Clinical Site
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Vega Baja, Puerto Rico, 693
- Kailera Clinical Site
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Madrid, Spanien, 28003
- Kailera Clinical Site
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Seville, Spanien, 41003
- Kailera Clinical Site
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Seville, Spanien, 41013
- Kailera Clinical Site
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Valencia, Spanien, 46014
- Kailera Clinical Site
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A Coruna
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Ferrol, A Coruna, Spanien, 15402
- Kailera Clinical Site
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Andalusia
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Seville, Andalusia, Spanien, 41010
- Kailera Clinical Site
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Cadiz
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Villamartín, Cadiz, Spanien, 11650
- Kailera Clinical Site
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Catalonia
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Barcelona, Catalonia, Spanien, 08035
- Kailera Clinical Site
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Principality of Asturias
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Oviedo, Principality of Asturias, Spanien, 33011
- Kailera Clinical Site
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Sevilla
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Castilleja de la Cuesta, Sevilla, Spanien, 41950
- Kailera Clinical Site
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Hodonín, Tjekkiet, 69501
- Kailera Clinical Site
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Olomouc, Tjekkiet, 77900
- Kailera Clinical Site
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Pardubice, Tjekkiet, 53002
- Kailera Clinical Site
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Prague, Tjekkiet, 15000
- Kailera Clinical Site
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Uherské Hradiště, Tjekkiet, 68601
- Kailera Clinical Site
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Central Bohemia
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Brandýs nad Labem, Central Bohemia, Tjekkiet, 25001
- Kailera Clinical Site
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Hradec Králové Region
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Náchod, Hradec Králové Region, Tjekkiet, 54701
- Kailera Clinical Site
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Trutnov, Hradec Králové Region, Tjekkiet, 54101
- Kailera Clinical Site
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Prague
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Bohnice, Prague, Tjekkiet, 18100
- Kailera Clinical Site
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Prague, Prague, Tjekkiet, 14059
- Kailera Clinical Site
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South Moravian
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Brno, South Moravian, Tjekkiet, 60200
- Kailera Clinical Site
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Zlín
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Holešov, Zlín, Tjekkiet, 76901
- Kailera Clinical Site
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Schwerin, Tyskland, 19055
- Kailera Clinical Site
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Baden-Wurttemberg
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Tübingen, Baden-Wurttemberg, Tyskland, 72076
- Kailera Clinical Site
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Brandenburg
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Falkensee, Brandenburg, Tyskland, 14612
- Kailera Clinical Site
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North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, Tyskland, 51069
- Kailera Clinical Site
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Essen, North Rhine-Westphalia, Tyskland, 45355
- Kailera Clinical Site #1
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Essen, North Rhine-Westphalia, Tyskland, 45355
- Kailera Clinical Site #2
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Schleswig-Holstein
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Oldenburg in Holstein, Schleswig-Holstein, Tyskland, 23758
- Kailera Clinical Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Key Inclusion Criteria:
- Diagnosis of type 2 diabetes mellitus (T2DM).
- Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive.
- BMI ≥27 kg/m^2.
- History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.
Key Exclusion Criteria:
- Current diagnosis or history of type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM.
- History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.
- History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening.
- Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, or phentermine.
- Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening.
- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
- Uncontrolled hypertension or unstable cardiovascular disease.
- History of chronic or acute pancreatitis.
- Known clinically significant gastric emptying abnormality or chronic treatment with medications that directly affect gastrointestinal (GI) motility if taken for >30 days continually within 3 months prior to Screening.
- History of suicide attempt.
- History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening.
- Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise within 3 months prior to Screening.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
5
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Ribupatide: Dose 1
Participants will receive Dose 1 of ribupatide once weekly. |
SC Injection
Andre navne:
|
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Eksperimentel: Ribupatide: Dose 2
Participants will receive Dose 2 of ribupatide once weekly. |
SC Injection
Andre navne:
|
|
Eksperimentel: Ribupatide: Dose 3
Participants will receive Dose 3 of ribupatide once weekly. |
SC Injection
Andre navne:
|
|
Eksperimentel: Ribupatide: Dose 4
Participants will receive Dose 4 of ribupatide once weekly. |
SC Injection
Andre navne:
|
|
Placebo komparator: Placebo
Participants will receive placebo matched to ribupatide once weekly. |
SC Injection |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Tidsramme: Baseline, Week 76
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Baseline, Week 76
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Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Tidsramme: Baseline, Week 76
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Baseline, Week 76
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Ændring fra baseline i taljeomkreds
Tidsramme: Baseline, uge 76
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Baseline, uge 76
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Ændring fra baseline i absolut kropsvægt
Tidsramme: Baseline, uge 76
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Baseline, uge 76
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Ændring fra baseline i systolisk blodtryk (SBP)
Tidsramme: Baseline, uge 76
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Baseline, uge 76
|
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Procentvis ændring fra udgangspunkt i fastende triglycerider
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
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Procentvis ændring fra baseline i fastende højdensitetslipoprotein (HDL)-kolesterol
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
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Procentvis ændring fra baseline i fastende ikke-HDL-kolesterol
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
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Ændring fra baseline i påvirkningen af vægt på livskvalitet - lite kliniske forsøgsversion (IWQOL-Lite-CT) fysisk funktionssammensat score
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
|
Procentdel af deltagere med ≥30 % reduktion i kropsvægt
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
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Ændring fra baseline i Control of Eating Questionnaire (CoEQ) Craving Control Score
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
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Ændring fra baseline i CoEQ Positivt Humør-score
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
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Ændring fra baseline i CoEQ-sult efter søde sager-score
Tidsramme: Baseline, uge 76
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Baseline, uge 76
|
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Ændring fra baseline i CoEQ craving for saltet mad score
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
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Ændring fra baseline i CoEQ Sult-score
Tidsramme: Baseline, uge 76
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Baseline, uge 76
|
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Ændring fra baseline i CoEQ-mæthedsscore
Tidsramme: Baseline, uge 76
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Baseline, uge 76
|
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Ændring fra baseline i CoEQ-kombineret score
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
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Ændring fra baseline i Food Noise Questionnaire (FNQ) score
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
|
Antal deltagere med behandlingsrelaterede bivirkninger (TEAE'er)
Tidsramme: Dag 1 op til uge 80
|
Dag 1 op til uge 80
|
|
Antal deltagere med anti-lægemiddel-antistoffer (ADA'er)
Tidsramme: Op til uge 80
|
Op til uge 80
|
|
Antal deltagere med neutraliserende antistoffer (Nabs)
Tidsramme: Op til uge 80
|
Op til uge 80
|
|
Procentdel af deltagere med ≥5%, ≥10%, ≥15%, ≥20% og ≥25% reduktion i kropsvægt
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
|
Ændring fra baseline i fastende blodsukker
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
|
Deltagere med Body Mass Index (BMI) ≥35 Kilogram per Kvadratmeter (kg/m²): Procentvis Ændring fra Baseline i Kropsvægt
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
|
Ændring fra baseline i BMI
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
|
Procentdel af deltagere med HbA1c <5,7%
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
|
Ændring fra baseline i diastolisk blodtryk (DBP)
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
|
Procentvis ændring fra baseline i fastende totalt kolesterol
Tidsramme: Udgangsniveau, uge 76
|
Udgangsniveau, uge 76
|
|
Procentvis ændring fra baseline i fastende lavtæthedslipoprotein (LDL)-kolesterol
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
|
Procentvis ændring fra baseline i meget lavtæthedslipoprotein (VLDL)-kolesterol
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
|
Procentvis ændring fra baseline i fastende insulin
Tidsramme: Baseline, uge 76
|
Baseline, uge 76
|
|
Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Tidsramme: Baseline, Week 76
|
Baseline, Week 76
|
|
Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Tidsramme: Baseline, Week 76
|
Baseline, Week 76
|
|
Percentage of Participants with HbA1c <7% and ≤6.5%
Tidsramme: Baseline, Week 76
|
Baseline, Week 76
|
|
Plasma Concentrations of Ribupatide
Tidsramme: Up to Week 76
|
Up to Week 76
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Medical Director, Kailera Therapeutics, Inc.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
12. januar 2026
Primær færdiggørelse (Anslået)
Primær færdiggørelse
27. marts 2028
Studieafslutning (Anslået)
Studieafslutning
24. april 2028
Datoer for studieregistrering
Først indsendt
Først indsendt
9. december 2025
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
9. december 2025
Først opslået (Faktiske)
Først opslået
16. december 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
6. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. oktober 2026
Sidst verificeret
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- K9531-3104
- 2025-523510-87-00 (Ctis)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .