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NCT07284979ClinicalTrials.gov

Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

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En resumen

The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.

Fase 31200 participantes buscados59 centros5 países

Categorías

Endocrino y metabólico100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2025-12-16; recorded start 2025-12-30
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 7 other studies in this databaseCounted from the lead sponsor named in the record (Kailera)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding13/20

    Double-blind

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 53 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,200 participants (target), run at 59 sites, across 5 countries.

How this score is built
  • Enrolment31/40

    1,200 participants (target)

  • Site count20/25

    53 sites

  • Country count7/15

    5 countries

  • Planned duration7/10

    Planned over about 27 months

  • Sponsor scale3/10

    Kailera has led 7 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.

Afecciones

  • Obesity

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Key Inclusion Criteria: * BMI ≥35 kilograms per square meter (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 diabetes mellitus. * 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, and phentermine. * Unstable weight defined as self-reported change in body weight exceeding 5% within the 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 motility. * History of suicide attempt. * History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder. * Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening. Note: Additional inclusion/exclusion criteria may apply, per protocol.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoDOUBLE (2)
Inscripción1200 participantes buscados

Patrocinador y colaboradores

  • Kailera Patrocinador

Grupos e intervenciones

  • Ribupatide: Dose 1EXPERIMENTAL

    Participants will receive Dose 1 of ribupatide once weekly.

  • Ribupatide: Dose 2EXPERIMENTAL

    Participants will receive Dose 2 of ribupatide once weekly.

  • SemaglutideACTIVE_COMPARATOR

    Participants will receive semaglutide once weekly.

  • PlaceboPLACEBO_COMPARATOR

    Participants will receive placebo matched to ribupatide once weekly.

Intervenciones

  • Fármaco Placebo

    SC Injection

  • Fármaco Ribupatide

    SC Injection

  • Fármaco Semaglutide

    SC Injection

Variables de resultado

  1. Variable de resultado principal

    Percent Change From Baseline in Body Weight at Week 76

    Plazo Baseline, Week 76

  2. Variable de resultado secundaria

    Percentage of Participants with ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight

    Plazo Baseline, Week 76

  3. Variable de resultado secundaria

    Change From Baseline in Waist Circumference

    Plazo Baseline, Week 76

  4. Variable de resultado secundaria

    Change From Baseline in Absolute Body Weight

    Plazo Baseline, Week 76

  5. Variable de resultado secundaria

    Percentage of Participants with ≥5% Reduction in Body Weight

    Plazo Baseline, Week 76

  6. Variable de resultado secundaria

    Change From Baseline in Systolic Blood Pressure (SBP)

    Plazo Baseline, Week 76

  7. Variable de resultado secundaria

    Percent Change From Baseline in Fasting Triglycerides

    Plazo Baseline, Week 76

  8. Variable de resultado secundaria

    Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol

    Plazo Baseline, Week 76

  9. Variable de resultado secundaria

    Percent Change From Baseline in Fasting Non-HDL-cholesterol

    Plazo Baseline, Week 76

  10. Variable de resultado secundaria

    Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score

    Plazo Baseline, Week 76

  11. Variable de resultado secundaria

    Percentage of Participants with ≥30% Reduction in Body Weight

    Plazo Baseline, Week 76

  12. Variable de resultado secundaria

    Change From Baseline in Body Mass Index (BMI)

    Plazo Baseline, Week 76

  13. Variable de resultado secundaria

    Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score

    Plazo Baseline, Week 76

  14. Variable de resultado secundaria

    Change From Baseline in CoEQ Positive Mood Score

    Plazo Baseline, Week 76

  15. Variable de resultado secundaria

    Change From Baseline in CoEQ Craving for Sweets Score

    Plazo Baseline, Week 76

  16. Variable de resultado secundaria

    Change From Baseline in CoEQ Craving for Savory Food Score

    Plazo Baseline, Week 76

  17. Variable de resultado secundaria

    Change From Baseline in CoEQ Hunger Score

    Plazo Baseline, Week 76

  18. Variable de resultado secundaria

    Change From Baseline in CoEQ Satiety Score

    Plazo Baseline, Week 76

  19. Variable de resultado secundaria

    Change From Baseline in CoEQ Combined Score

    Plazo Baseline, Week 76

  20. Variable de resultado secundaria

    Change From Baseline in Food Noise Questionnaire (FNQ) Score

    Plazo Baseline, Week 76

  21. Variable de resultado secundaria

    Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Plazo Day 1 up to Week 80

  22. Variable de resultado secundaria

    Number of Participants With Anti-drug Antibodies (ADAs)

    Plazo Up to Week 80

  23. Variable de resultado secundaria

    Number of Participants With Neutralizing Antibodies (Nabs)

    Plazo Up to Week 80

  24. Variable de resultado secundaria

    Plasma Concentrations of Ribupatide

    Plazo Up to Week 76

Fechas

Fecha de inicio30 de diciembre de 2025 (real)
Finalización principal1 de marzo de 2028 (estimada)
Finalización1 de abril de 2028 (estimada)
Primera publicación16 de diciembre de 2025 (real)
Última actualización1 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezagosto de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

59 centros están en reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Kailera Clinical SiteBlacktownNew South WalesEn reclutamiento
Kailera Clinical SiteBruceAustralian Capital TerritoryEn reclutamiento
Kailera Clinical SiteCamberwellVictoriaEn reclutamiento
Kailera Clinical SiteHerstonQueenslandEn reclutamiento
Kailera Clinical SiteKanwalNew South WalesEn reclutamiento
Kailera Clinical SiteMorayfieldQueenslandEn reclutamiento
Kailera Clinical SiteSouth BrisbaneQueenslandEn reclutamiento

Bulgaria

CentroCiudadEstado o regiónEstado
Kailera Clinical SiteMontanaEn reclutamiento
Kailera Clinical SitePlevenPleven ProvinceEn reclutamiento
Kailera Clinical SitePlovdivPlovdiv ProvinceEn reclutamiento
Kailera Clinical SiteSofiaSofiaEn reclutamiento
Kailera Clinical SiteSofiaEn reclutamiento
Kailera Clinical SiteSofiaEn reclutamiento
Kailera Clinical SiteSofiaSofiaEn reclutamiento
Kailera Clinical SiteStara ZagoraEn reclutamiento
Kailera Clinical SiteVarnaVarna ProvinceEn reclutamiento

Poland

CentroCiudadEstado o regiónEstado
Kailera Clinical SiteBydgoszczEn reclutamiento
Kailera Clinical SiteChorzówSilesian VoivodeshipEn reclutamiento
Kailera Clinical SiteGdyniaEn reclutamiento
Kailera Clinical SiteGdyniaPomeranian VoivodeshipEn reclutamiento
Kailera Clinical SiteKielceŚwiętokrzyskie VoivodeshipEn reclutamiento
Kailera Clinical SiteKrakowLesser Poland VoivodeshipEn reclutamiento
Kailera Clinical SiteWarsawMasovian VoivodeshipEn reclutamiento
Kailera Clinical SiteWroclawEn reclutamiento

United Kingdom

CentroCiudadEstado o regiónEstado
Kailera Clinical SiteExeterDevonEn reclutamiento
Kailera Clinical SiteGlasgowGlasgow CityEn reclutamiento
Kailera Clinical SiteLeicesterLeicestershireEn reclutamiento
Kailera Clinical SiteLondonGreater LondonEn reclutamiento
Kailera Clinical SiteLondonGreater LondonEn reclutamiento
Kailera Clinical SiteRotherhamSouth YorkshireEn reclutamiento
Kailera Clinical SiteTorquayDevonEn reclutamiento
Kailera Clinical SiteWeymouthDorsetEn reclutamiento

United States

CentroCiudadEstado o regiónEstado
Kailera Clinical SiteAlbanyGeorgiaEn reclutamiento
Kailera Clinical SiteAlbanyNew YorkEn reclutamiento
Kailera Clinical SiteBrownsvilleTexasEn reclutamiento
Kailera Clinical SiteChicagoIllinoisEn reclutamiento
Kailera Clinical SiteEast GreenwichRhode IslandEn reclutamiento
Kailera Clinical SiteFarmington HillsMichiganEn reclutamiento
Kailera Clinical SiteGlendaleArizonaEn reclutamiento
Kailera Clinical SiteHamdenConnecticutEn reclutamiento
Kailera Clinical SiteLas VegasNevadaEn reclutamiento
Kailera Clinical SiteLittle RockArkansasEn reclutamiento
Kailera Clinical SiteManassasVirginiaEn reclutamiento
Kailera Clinical SiteMissoulaMontanaEn reclutamiento
Kailera Clinical SiteMorehead CityNorth CarolinaEn reclutamiento
Kailera Clinical SiteMorrisvilleNorth CarolinaEn reclutamiento
Kailera Clinical SiteNewtonKansasEn reclutamiento
Kailera Clinical SiteNormanOklahomaEn reclutamiento
Kailera Clinical SiteNorth CharlestonSouth CarolinaEn reclutamiento
Kailera Clinical SiteNorthridgeCaliforniaEn reclutamiento

En el registro figuran 9 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 1 de septiembre de 2026

    Centro añadido

    6 sites added (59 total)

    5359

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07284979