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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati167 centri11 paesi

Categorie

Endocrino e metabolico100%

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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)

Patologie

  • Obesity With Diabetes
  • Overweight With Diabetes

Idoneità

SessoTutti
Età18 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel 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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoDOUBLE (2)
Arruolamento1156 partecipanti ricercati

Sponsor e collaboratori

  • Kailera Sponsor

Bracci e interventi

  • 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.

Interventi

  • Farmaco Placebo

    SC Injection

  • Farmaco Ribupatide

    SC Injection

Esiti misurati

  1. Esito primario

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

    Orizzonte temporale Baseline, Week 76

  2. Esito primario

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

    Orizzonte temporale Baseline, Week 76

  3. Esito secondario

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

    Orizzonte temporale Baseline, Week 76

  4. Esito secondario

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

    Orizzonte temporale Baseline, Week 76

  5. Esito secondario

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

    Orizzonte temporale Baseline, Week 76

  6. Esito secondario

    Change From Baseline in Waist Circumference

    Orizzonte temporale Baseline, Week 76

  7. Esito secondario

    Change From Baseline in Absolute Body Weight

    Orizzonte temporale Baseline, Week 76

  8. Esito secondario

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

    Orizzonte temporale Baseline, Week 76

  9. Esito secondario

    Change From Baseline in Fasting Blood Glucose

    Orizzonte temporale Baseline, Week 76

  10. Esito secondario

    Change From Baseline in Systolic Blood Pressure (SBP)

    Orizzonte temporale Baseline, Week 76

  11. Esito secondario

    Percent Change From Baseline in Fasting Triglycerides

    Orizzonte temporale Baseline, Week 76

  12. Esito secondario

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

    Orizzonte temporale Baseline, Week 76

  13. Esito secondario

    Percent Change From Baseline in Fasting Non-HDL-cholesterol

    Orizzonte temporale Baseline, Week 76

  14. Esito secondario

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

    Orizzonte temporale Baseline, Week 76

  15. Esito secondario

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

    Orizzonte temporale Baseline, Week 76

  16. Esito secondario

    Percentage of Participants with ≥30% Reduction in Body Weight

    Orizzonte temporale Baseline, Week 76

  17. Esito secondario

    Change From Baseline in BMI

    Orizzonte temporale Baseline, Week 76

  18. Esito secondario

    Percentage of Participants with HbA1c <5.7%

    Orizzonte temporale Baseline, Week 76

  19. Esito secondario

    Change From Baseline in Diastolic Blood Pressure (DBP)

    Orizzonte temporale Baseline, Week 76

  20. Esito secondario

    Percent Change From Baseline in Fasting Total Cholesterol

    Orizzonte temporale Baseline, Week 76

  21. Esito secondario

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

    Orizzonte temporale Baseline, Week 76

  22. Esito secondario

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

    Orizzonte temporale Baseline, Week 76

  23. Esito secondario

    Percent Change From Baseline in Fasting Insulin

    Orizzonte temporale Baseline, Week 76

  24. Esito secondario

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

    Orizzonte temporale Baseline, Week 76

  25. Esito secondario

    Change From Baseline in CoEQ Positive Mood Score

    Orizzonte temporale Baseline, Week 76

  26. Esito secondario

    Change From Baseline in CoEQ Craving for Sweets Score

    Orizzonte temporale Baseline, Week 76

  27. Esito secondario

    Change From Baseline in CoEQ Craving for Savory Food Score

    Orizzonte temporale Baseline, Week 76

  28. Esito secondario

    Change From Baseline in CoEQ Hunger Score

    Orizzonte temporale Baseline, Week 76

  29. Esito secondario

    Change From Baseline in CoEQ Satiety Score

    Orizzonte temporale Baseline, Week 76

  30. Esito secondario

    Change From Baseline in CoEQ Combined Score

    Orizzonte temporale Baseline, Week 76

  31. Esito secondario

    Change From Baseline in Food Noise Questionnaire (FNQ) Score

    Orizzonte temporale Baseline, Week 76

  32. Esito secondario

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

    Orizzonte temporale Day 1 up to Week 80

  33. Esito secondario

    Number of Participants With Anti-drug Antibodies (ADAs)

    Orizzonte temporale Up to Week 80

  34. Esito secondario

    Number of Participants With Neutralizing Antibodies (Nabs)

    Orizzonte temporale Up to Week 80

  35. Esito secondario

    Plasma Concentrations of Ribupatide

    Orizzonte temporale Up to Week 76

Date

Data di inizio12 gennaio 2026 (effettiva)
Conclusione primaria27 marzo 2028 (stimata)
Conclusione24 aprile 2028 (stimata)
Prima pubblicazione16 dicembre 2025 (effettiva)
Ultimo aggiornamento3 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

165 centri stanno reclutando

Argentina

StrutturaCittàStato o regioneStato
Kailera Clinical SiteBuenos AiresIn reclutamento
Kailera Clinical SiteBuenos AiresIn reclutamento
Kailera Clinical SiteBuenos AiresIn reclutamento
Kailera Clinical SiteBuenos AiresIn reclutamento
Kailera Clinical SiteCiudad Autonoma de Buenos AiresBuenos AiresIn reclutamento
Kailera Clinical SiteCórdobaIn reclutamento
Kailera Clinical SiteCórdobaIn reclutamento
Kailera Clinical SiteGodoy CruzMendoza ProvinceIn reclutamento
Kailera Clinical SiteLa PlataBuenos AiresIn reclutamento
Kailera Clinical SiteMar del PlataBuenos AiresIn reclutamento
Kailera Clinical SiteRosarioSanta Fe ProvinceIn reclutamento
Kailera Clinical SiteRosarioSante FeIn reclutamento
Kailera Clinical SiteSan Nicolás de los ArroyosBuenos AiresIn reclutamento
Kailera Clinical SiteZárateBuenos AiresIn reclutamento

Australia

StrutturaCittàStato o regioneStato
Kailera Clinical SiteBlacktownNew South WalesIn reclutamento
Kailera Clinical SiteBruceAustralian Capital TerritoryIn reclutamento
Kailera Clinical SiteCamberwellVictoriaIn reclutamento
Kailera Clinical SiteCharlestownNew South WalesIn reclutamento
Kailera Clinical SiteHerstonQueenslandIn reclutamento
Kailera Clinical SiteKanwalNew South WalesIn reclutamento
Kailera Clinical SiteLeichhardtNew South WalesIn reclutamento
Kailera Clinical SiteMelbourneVictoriaIn reclutamento
Kailera Clinical SiteMorayfieldQueenslandIn reclutamento
Kailera Clinical SitePenrithNew South WalesIn reclutamento
Kailera Clinical SiteSouth BrisbaneIn reclutamento
Kailera Clinical SiteSydneyNew South WalesIn reclutamento
Kailera Clinical SiteSydneyNew South WalesIn reclutamento
Kailera Clinical SiteWollongongNew South WalesIn reclutamento

Bulgaria

StrutturaCittàStato o regioneStato
Kailera Clinical SiteKyustendilKyustendil ProvinceIn reclutamento
Kailera Clinical SiteMontanaIn reclutamento
Kailera Clinical SitePlevenPleven ProvinceIn reclutamento
Kailera Clinical SitePlovdivPlovdiv ProvinceIn reclutamento
Kailera Clinical SiteRousseRuse ProvinceIn reclutamento
Kailera Clinical SiteSofiaSofiaIn reclutamento
Kailera Clinical SiteSofiaSofiaIn reclutamento
Kailera Clinical SiteSofiaSofiaIn reclutamento
Kailera Clinical SiteStara ZagoraStara Zagora ProvinceIn reclutamento
Kailera Clinical SiteVarnaVarna ProvinceIn reclutamento

Czechia

StrutturaCittàStato o regioneStato
Kailera Clinical SiteBohnicePragueIn reclutamento
Kailera Clinical SiteBrandýs nad LabemCentral BohemiaIn reclutamento
Kailera Clinical SiteBrnoSouth MoravianIn reclutamento
Kailera Clinical SiteHodonínIn reclutamento
Kailera Clinical SiteHolešovZlínIn reclutamento
Kailera Clinical SiteNáchodHradec Králové RegionIn reclutamento
Kailera Clinical SiteOlomoucIn reclutamento
Kailera Clinical SitePardubiceIn reclutamento
Kailera Clinical SitePragueIn reclutamento
Kailera Clinical SitePraguePragueIn reclutamento
Kailera Clinical SiteTrutnovHradec Králové RegionIn reclutamento
Kailera Clinical SiteUherské HradištěIn reclutamento

Nella scheda del registro sono indicati altri 117 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 3 settembre 2026

    Centro aggiunto

    4 sites added (167 total)

    163167

  2. 1 settembre 2026

    Centro aggiunto

    47 sites added (163 total)

    116163

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

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