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NCT07284901ClinicalTrials.gov

Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and 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 placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)

Fase 31156 participantes buscados167 centros11 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 2026-01-12
  • 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 2 conditions.
  • 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 rigourSTRONG

A strong methodological 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 arm13/15

    Placebo / sham 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: 116 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: 1,156 participants (target), run at 167 sites, across 11 countries.

How this score is built
  • Enrolment30/40

    1,156 participants (target)

  • Site count23/25

    116 sites

  • Country count12/15

    11 countries

  • Planned duration7/10

    Planned over about 28 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 placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)

Afecciones

  • Obesity With Diabetes
  • Overweight With Diabetes

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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.

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)
Inscripción1156 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.

  • Ribupatide: Dose 3EXPERIMENTAL

    Participants will receive Dose 3 of ribupatide once weekly.

  • Ribupatide: Dose 4EXPERIMENTAL

    Participants will receive Dose 4 of ribupatide once weekly.

  • PlaceboPLACEBO_COMPARATOR

    Participants will receive placebo matched to ribupatide once weekly.

Intervenciones

  • Fármaco Placebo

    SC Injection

  • Fármaco Ribupatide

    SC Injection

Variables de resultado

  1. Variable de resultado principal

    Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

    Plazo Baseline, Week 76

  2. Variable de resultado principal

    Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76

    Plazo Baseline, Week 76

  3. Variable de resultado secundaria

    Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

    Plazo Baseline, Week 76

  4. Variable de resultado secundaria

    Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76

    Plazo Baseline, Week 76

  5. Variable de resultado secundaria

    Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight

    Plazo Baseline, Week 76

  6. Variable de resultado secundaria

    Change From Baseline in Waist Circumference

    Plazo Baseline, Week 76

  7. Variable de resultado secundaria

    Change From Baseline in Absolute Body Weight

    Plazo Baseline, Week 76

  8. Variable de resultado secundaria

    Percentage of Participants with HbA1c <7% and ≤6.5%

    Plazo Baseline, Week 76

  9. Variable de resultado secundaria

    Change From Baseline in Fasting Blood Glucose

    Plazo Baseline, Week 76

  10. Variable de resultado secundaria

    Change From Baseline in Systolic Blood Pressure (SBP)

    Plazo Baseline, Week 76

  11. Variable de resultado secundaria

    Percent Change From Baseline in Fasting Triglycerides

    Plazo Baseline, Week 76

  12. Variable de resultado secundaria

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

    Plazo Baseline, Week 76

  13. Variable de resultado secundaria

    Percent Change From Baseline in Fasting Non-HDL-cholesterol

    Plazo Baseline, Week 76

  14. 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

  15. Variable de resultado secundaria

    Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight

    Plazo Baseline, Week 76

  16. Variable de resultado secundaria

    Percentage of Participants with ≥30% Reduction in Body Weight

    Plazo Baseline, Week 76

  17. Variable de resultado secundaria

    Change From Baseline in BMI

    Plazo Baseline, Week 76

  18. Variable de resultado secundaria

    Percentage of Participants with HbA1c <5.7%

    Plazo Baseline, Week 76

  19. Variable de resultado secundaria

    Change From Baseline in Diastolic Blood Pressure (DBP)

    Plazo Baseline, Week 76

  20. Variable de resultado secundaria

    Percent Change From Baseline in Fasting Total Cholesterol

    Plazo Baseline, Week 76

  21. Variable de resultado secundaria

    Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol

    Plazo Baseline, Week 76

  22. Variable de resultado secundaria

    Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol

    Plazo Baseline, Week 76

  23. Variable de resultado secundaria

    Percent Change From Baseline in Fasting Insulin

    Plazo Baseline, Week 76

  24. Variable de resultado secundaria

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

    Plazo Baseline, Week 76

  25. Variable de resultado secundaria

    Change From Baseline in CoEQ Positive Mood Score

    Plazo Baseline, Week 76

  26. Variable de resultado secundaria

    Change From Baseline in CoEQ Craving for Sweets Score

    Plazo Baseline, Week 76

  27. Variable de resultado secundaria

    Change From Baseline in CoEQ Craving for Savory Food Score

    Plazo Baseline, Week 76

  28. Variable de resultado secundaria

    Change From Baseline in CoEQ Hunger Score

    Plazo Baseline, Week 76

  29. Variable de resultado secundaria

    Change From Baseline in CoEQ Satiety Score

    Plazo Baseline, Week 76

  30. Variable de resultado secundaria

    Change From Baseline in CoEQ Combined Score

    Plazo Baseline, Week 76

  31. Variable de resultado secundaria

    Change From Baseline in Food Noise Questionnaire (FNQ) Score

    Plazo Baseline, Week 76

  32. Variable de resultado secundaria

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

    Plazo Day 1 up to Week 80

  33. Variable de resultado secundaria

    Number of Participants With Anti-drug Antibodies (ADAs)

    Plazo Up to Week 80

  34. Variable de resultado secundaria

    Number of Participants With Neutralizing Antibodies (Nabs)

    Plazo Up to Week 80

  35. Variable de resultado secundaria

    Plasma Concentrations of Ribupatide

    Plazo Up to Week 76

Fechas

Fecha de inicio12 de enero de 2026 (real)
Finalización principal27 de marzo de 2028 (estimada)
Finalización24 de abril de 2028 (estimada)
Primera publicación16 de diciembre de 2025 (real)
Última actualización3 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

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

Ubicaciones

165 centros están en reclutamiento

Argentina

CentroCiudadEstado o regiónEstado
Kailera Clinical SiteBuenos AiresEn reclutamiento
Kailera Clinical SiteBuenos AiresEn reclutamiento
Kailera Clinical SiteBuenos AiresEn reclutamiento
Kailera Clinical SiteBuenos AiresEn reclutamiento
Kailera Clinical SiteCiudad Autonoma de Buenos AiresBuenos AiresEn reclutamiento
Kailera Clinical SiteCórdobaEn reclutamiento
Kailera Clinical SiteCórdobaEn reclutamiento
Kailera Clinical SiteGodoy CruzMendoza ProvinceEn reclutamiento
Kailera Clinical SiteLa PlataBuenos AiresEn reclutamiento
Kailera Clinical SiteMar del PlataBuenos AiresEn reclutamiento
Kailera Clinical SiteRosarioSanta Fe ProvinceEn reclutamiento
Kailera Clinical SiteRosarioSante FeEn reclutamiento
Kailera Clinical SiteSan Nicolás de los ArroyosBuenos AiresEn reclutamiento
Kailera Clinical SiteZárateBuenos AiresEn reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Kailera Clinical SiteBlacktownNew South WalesEn reclutamiento
Kailera Clinical SiteBruceAustralian Capital TerritoryEn reclutamiento
Kailera Clinical SiteCamberwellVictoriaEn reclutamiento
Kailera Clinical SiteCharlestownNew South WalesEn reclutamiento
Kailera Clinical SiteHerstonQueenslandEn reclutamiento
Kailera Clinical SiteKanwalNew South WalesEn reclutamiento
Kailera Clinical SiteLeichhardtNew South WalesEn reclutamiento
Kailera Clinical SiteMelbourneVictoriaEn reclutamiento
Kailera Clinical SiteMorayfieldQueenslandEn reclutamiento
Kailera Clinical SitePenrithNew South WalesEn reclutamiento
Kailera Clinical SiteSouth BrisbaneEn reclutamiento
Kailera Clinical SiteSydneyNew South WalesEn reclutamiento
Kailera Clinical SiteSydneyNew South WalesEn reclutamiento
Kailera Clinical SiteWollongongNew South WalesEn reclutamiento

Bulgaria

CentroCiudadEstado o regiónEstado
Kailera Clinical SiteKyustendilKyustendil ProvinceEn reclutamiento
Kailera Clinical SiteMontanaEn reclutamiento
Kailera Clinical SitePlevenPleven ProvinceEn reclutamiento
Kailera Clinical SitePlovdivPlovdiv ProvinceEn reclutamiento
Kailera Clinical SiteRousseRuse ProvinceEn reclutamiento
Kailera Clinical SiteSofiaSofiaEn reclutamiento
Kailera Clinical SiteSofiaSofiaEn reclutamiento
Kailera Clinical SiteSofiaSofiaEn reclutamiento
Kailera Clinical SiteStara ZagoraStara Zagora ProvinceEn reclutamiento
Kailera Clinical SiteVarnaVarna ProvinceEn reclutamiento

Czechia

CentroCiudadEstado o regiónEstado
Kailera Clinical SiteBohnicePragueEn reclutamiento
Kailera Clinical SiteBrandýs nad LabemCentral BohemiaEn reclutamiento
Kailera Clinical SiteBrnoSouth MoravianEn reclutamiento
Kailera Clinical SiteHodonínEn reclutamiento
Kailera Clinical SiteHolešovZlínEn reclutamiento
Kailera Clinical SiteNáchodHradec Králové RegionEn reclutamiento
Kailera Clinical SiteOlomoucEn reclutamiento
Kailera Clinical SitePardubiceEn reclutamiento
Kailera Clinical SitePragueEn reclutamiento
Kailera Clinical SitePraguePragueEn reclutamiento
Kailera Clinical SiteTrutnovHradec Králové RegionEn reclutamiento
Kailera Clinical SiteUherské HradištěEn reclutamiento

En el registro figuran 117 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 3 de septiembre de 2026

    Centro añadido

    4 sites added (167 total)

    163167

  2. 1 de septiembre de 2026

    Centro añadido

    47 sites added (163 total)

    116163

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

https://xmedica.io/trials/ctgov/NCT07284901