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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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.

Phase 31 200 participants recherchés59 sites5 pays

Catégories

Endocrinien et métabolique100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Obesity

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuDOUBLE (2)
Recrutement1 200 participants recherchés

Promoteur et collaborateurs

  • Kailera Promoteur

Groupes et interventions

  • 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.

Interventions

  • Médicament Placebo

    SC Injection

  • Médicament Ribupatide

    SC Injection

  • Médicament Semaglutide

    SC Injection

Critères de jugement

  1. Critère de jugement principal

    Percent Change From Baseline in Body Weight at Week 76

    Délai Baseline, Week 76

  2. Critère de jugement secondaire

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

    Délai Baseline, Week 76

  3. Critère de jugement secondaire

    Change From Baseline in Waist Circumference

    Délai Baseline, Week 76

  4. Critère de jugement secondaire

    Change From Baseline in Absolute Body Weight

    Délai Baseline, Week 76

  5. Critère de jugement secondaire

    Percentage of Participants with ≥5% Reduction in Body Weight

    Délai Baseline, Week 76

  6. Critère de jugement secondaire

    Change From Baseline in Systolic Blood Pressure (SBP)

    Délai Baseline, Week 76

  7. Critère de jugement secondaire

    Percent Change From Baseline in Fasting Triglycerides

    Délai Baseline, Week 76

  8. Critère de jugement secondaire

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

    Délai Baseline, Week 76

  9. Critère de jugement secondaire

    Percent Change From Baseline in Fasting Non-HDL-cholesterol

    Délai Baseline, Week 76

  10. Critère de jugement secondaire

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

    Délai Baseline, Week 76

  11. Critère de jugement secondaire

    Percentage of Participants with ≥30% Reduction in Body Weight

    Délai Baseline, Week 76

  12. Critère de jugement secondaire

    Change From Baseline in Body Mass Index (BMI)

    Délai Baseline, Week 76

  13. Critère de jugement secondaire

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

    Délai Baseline, Week 76

  14. Critère de jugement secondaire

    Change From Baseline in CoEQ Positive Mood Score

    Délai Baseline, Week 76

  15. Critère de jugement secondaire

    Change From Baseline in CoEQ Craving for Sweets Score

    Délai Baseline, Week 76

  16. Critère de jugement secondaire

    Change From Baseline in CoEQ Craving for Savory Food Score

    Délai Baseline, Week 76

  17. Critère de jugement secondaire

    Change From Baseline in CoEQ Hunger Score

    Délai Baseline, Week 76

  18. Critère de jugement secondaire

    Change From Baseline in CoEQ Satiety Score

    Délai Baseline, Week 76

  19. Critère de jugement secondaire

    Change From Baseline in CoEQ Combined Score

    Délai Baseline, Week 76

  20. Critère de jugement secondaire

    Change From Baseline in Food Noise Questionnaire (FNQ) Score

    Délai Baseline, Week 76

  21. Critère de jugement secondaire

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

    Délai Day 1 up to Week 80

  22. Critère de jugement secondaire

    Number of Participants With Anti-drug Antibodies (ADAs)

    Délai Up to Week 80

  23. Critère de jugement secondaire

    Number of Participants With Neutralizing Antibodies (Nabs)

    Délai Up to Week 80

  24. Critère de jugement secondaire

    Plasma Concentrations of Ribupatide

    Délai Up to Week 76

Dates

Date de début30 décembre 2025 (réelle)
Achèvement principal1 mars 2028 (estimée)
Achèvement1 avril 2028 (estimée)
Première publication16 décembre 2025 (réelle)
Dernière mise à jour1 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisaoût 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

59 sites sont en recrutement

Australia

ÉtablissementVilleÉtat ou régionStatut
Kailera Clinical SiteBlacktownNew South WalesEn recrutement
Kailera Clinical SiteBruceAustralian Capital TerritoryEn recrutement
Kailera Clinical SiteCamberwellVictoriaEn recrutement
Kailera Clinical SiteHerstonQueenslandEn recrutement
Kailera Clinical SiteKanwalNew South WalesEn recrutement
Kailera Clinical SiteMorayfieldQueenslandEn recrutement
Kailera Clinical SiteSouth BrisbaneQueenslandEn recrutement

Bulgaria

ÉtablissementVilleÉtat ou régionStatut
Kailera Clinical SiteMontanaEn recrutement
Kailera Clinical SitePlevenPleven ProvinceEn recrutement
Kailera Clinical SitePlovdivPlovdiv ProvinceEn recrutement
Kailera Clinical SiteSofiaSofiaEn recrutement
Kailera Clinical SiteSofiaEn recrutement
Kailera Clinical SiteSofiaEn recrutement
Kailera Clinical SiteSofiaSofiaEn recrutement
Kailera Clinical SiteStara ZagoraEn recrutement
Kailera Clinical SiteVarnaVarna ProvinceEn recrutement

Poland

ÉtablissementVilleÉtat ou régionStatut
Kailera Clinical SiteBydgoszczEn recrutement
Kailera Clinical SiteChorzówSilesian VoivodeshipEn recrutement
Kailera Clinical SiteGdyniaEn recrutement
Kailera Clinical SiteGdyniaPomeranian VoivodeshipEn recrutement
Kailera Clinical SiteKielceŚwiętokrzyskie VoivodeshipEn recrutement
Kailera Clinical SiteKrakowLesser Poland VoivodeshipEn recrutement
Kailera Clinical SiteWarsawMasovian VoivodeshipEn recrutement
Kailera Clinical SiteWroclawEn recrutement

United Kingdom

ÉtablissementVilleÉtat ou régionStatut
Kailera Clinical SiteExeterDevonEn recrutement
Kailera Clinical SiteGlasgowGlasgow CityEn recrutement
Kailera Clinical SiteLeicesterLeicestershireEn recrutement
Kailera Clinical SiteLondonGreater LondonEn recrutement
Kailera Clinical SiteLondonGreater LondonEn recrutement
Kailera Clinical SiteRotherhamSouth YorkshireEn recrutement
Kailera Clinical SiteTorquayDevonEn recrutement
Kailera Clinical SiteWeymouthDorsetEn recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
Kailera Clinical SiteAlbanyGeorgiaEn recrutement
Kailera Clinical SiteAlbanyNew YorkEn recrutement
Kailera Clinical SiteBrownsvilleTexasEn recrutement
Kailera Clinical SiteChicagoIllinoisEn recrutement
Kailera Clinical SiteEast GreenwichRhode IslandEn recrutement
Kailera Clinical SiteFarmington HillsMichiganEn recrutement
Kailera Clinical SiteGlendaleArizonaEn recrutement
Kailera Clinical SiteHamdenConnecticutEn recrutement
Kailera Clinical SiteLas VegasNevadaEn recrutement
Kailera Clinical SiteLittle RockArkansasEn recrutement
Kailera Clinical SiteManassasVirginiaEn recrutement
Kailera Clinical SiteMissoulaMontanaEn recrutement
Kailera Clinical SiteMorehead CityNorth CarolinaEn recrutement
Kailera Clinical SiteMorrisvilleNorth CarolinaEn recrutement
Kailera Clinical SiteNewtonKansasEn recrutement
Kailera Clinical SiteNormanOklahomaEn recrutement
Kailera Clinical SiteNorth CharlestonSouth CarolinaEn recrutement
Kailera Clinical SiteNorthridgeCaliforniaEn recrutement

9 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 1 septembre 2026

    Site ajouté

    6 sites added (59 total)

    5359

Registre: ClinicalTrials.gov · NCT########

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