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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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.
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Kurz gefasst

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 Teilnehmende gesucht59 Studienzentren5 Länder

Kategorien

Endokrin und metabolisch100%

In 1 Register registriert

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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.

Zusammenfassung

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.

Erkrankungen

  • Obesity

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungDOUBLE (2)
Teilnahme1.200 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Kailera Sponsor

Studienarme und Interventionen

  • 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.

Interventionen

  • Arzneimittel Placebo

    SC Injection

  • Arzneimittel Ribupatide

    SC Injection

  • Arzneimittel Semaglutide

    SC Injection

Endpunkte

  1. Primärer Endpunkt

    Percent Change From Baseline in Body Weight at Week 76

    Zeitrahmen Baseline, Week 76

  2. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  3. Sekundärer Endpunkt

    Change From Baseline in Waist Circumference

    Zeitrahmen Baseline, Week 76

  4. Sekundärer Endpunkt

    Change From Baseline in Absolute Body Weight

    Zeitrahmen Baseline, Week 76

  5. Sekundärer Endpunkt

    Percentage of Participants with ≥5% Reduction in Body Weight

    Zeitrahmen Baseline, Week 76

  6. Sekundärer Endpunkt

    Change From Baseline in Systolic Blood Pressure (SBP)

    Zeitrahmen Baseline, Week 76

  7. Sekundärer Endpunkt

    Percent Change From Baseline in Fasting Triglycerides

    Zeitrahmen Baseline, Week 76

  8. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  9. Sekundärer Endpunkt

    Percent Change From Baseline in Fasting Non-HDL-cholesterol

    Zeitrahmen Baseline, Week 76

  10. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  11. Sekundärer Endpunkt

    Percentage of Participants with ≥30% Reduction in Body Weight

    Zeitrahmen Baseline, Week 76

  12. Sekundärer Endpunkt

    Change From Baseline in Body Mass Index (BMI)

    Zeitrahmen Baseline, Week 76

  13. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  14. Sekundärer Endpunkt

    Change From Baseline in CoEQ Positive Mood Score

    Zeitrahmen Baseline, Week 76

  15. Sekundärer Endpunkt

    Change From Baseline in CoEQ Craving for Sweets Score

    Zeitrahmen Baseline, Week 76

  16. Sekundärer Endpunkt

    Change From Baseline in CoEQ Craving for Savory Food Score

    Zeitrahmen Baseline, Week 76

  17. Sekundärer Endpunkt

    Change From Baseline in CoEQ Hunger Score

    Zeitrahmen Baseline, Week 76

  18. Sekundärer Endpunkt

    Change From Baseline in CoEQ Satiety Score

    Zeitrahmen Baseline, Week 76

  19. Sekundärer Endpunkt

    Change From Baseline in CoEQ Combined Score

    Zeitrahmen Baseline, Week 76

  20. Sekundärer Endpunkt

    Change From Baseline in Food Noise Questionnaire (FNQ) Score

    Zeitrahmen Baseline, Week 76

  21. Sekundärer Endpunkt

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

    Zeitrahmen Day 1 up to Week 80

  22. Sekundärer Endpunkt

    Number of Participants With Anti-drug Antibodies (ADAs)

    Zeitrahmen Up to Week 80

  23. Sekundärer Endpunkt

    Number of Participants With Neutralizing Antibodies (Nabs)

    Zeitrahmen Up to Week 80

  24. Sekundärer Endpunkt

    Plasma Concentrations of Ribupatide

    Zeitrahmen Up to Week 76

Daten

Startdatum30. Dezember 2025 (tatsächlich)
Primärer Abschluss1. März 2028 (geschätzt)
Abschluss1. April 2028 (geschätzt)
Erstveröffentlichung16. Dezember 2025 (tatsächlich)
Zuletzt aktualisiert1. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtAugust 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

59 Studienzentren rekrutieren

Australia

EinrichtungStadtBundesland oder RegionStatus
Kailera Clinical SiteBlacktownNew South WalesRekrutiert
Kailera Clinical SiteBruceAustralian Capital TerritoryRekrutiert
Kailera Clinical SiteCamberwellVictoriaRekrutiert
Kailera Clinical SiteHerstonQueenslandRekrutiert
Kailera Clinical SiteKanwalNew South WalesRekrutiert
Kailera Clinical SiteMorayfieldQueenslandRekrutiert
Kailera Clinical SiteSouth BrisbaneQueenslandRekrutiert

Bulgaria

EinrichtungStadtBundesland oder RegionStatus
Kailera Clinical SiteMontanaRekrutiert
Kailera Clinical SitePlevenPleven ProvinceRekrutiert
Kailera Clinical SitePlovdivPlovdiv ProvinceRekrutiert
Kailera Clinical SiteSofiaSofiaRekrutiert
Kailera Clinical SiteSofiaRekrutiert
Kailera Clinical SiteSofiaRekrutiert
Kailera Clinical SiteSofiaSofiaRekrutiert
Kailera Clinical SiteStara ZagoraRekrutiert
Kailera Clinical SiteVarnaVarna ProvinceRekrutiert

Poland

EinrichtungStadtBundesland oder RegionStatus
Kailera Clinical SiteBydgoszczRekrutiert
Kailera Clinical SiteChorzówSilesian VoivodeshipRekrutiert
Kailera Clinical SiteGdyniaRekrutiert
Kailera Clinical SiteGdyniaPomeranian VoivodeshipRekrutiert
Kailera Clinical SiteKielceŚwiętokrzyskie VoivodeshipRekrutiert
Kailera Clinical SiteKrakowLesser Poland VoivodeshipRekrutiert
Kailera Clinical SiteWarsawMasovian VoivodeshipRekrutiert
Kailera Clinical SiteWroclawRekrutiert

United Kingdom

EinrichtungStadtBundesland oder RegionStatus
Kailera Clinical SiteExeterDevonRekrutiert
Kailera Clinical SiteGlasgowGlasgow CityRekrutiert
Kailera Clinical SiteLeicesterLeicestershireRekrutiert
Kailera Clinical SiteLondonGreater LondonRekrutiert
Kailera Clinical SiteLondonGreater LondonRekrutiert
Kailera Clinical SiteRotherhamSouth YorkshireRekrutiert
Kailera Clinical SiteTorquayDevonRekrutiert
Kailera Clinical SiteWeymouthDorsetRekrutiert

United States

EinrichtungStadtBundesland oder RegionStatus
Kailera Clinical SiteAlbanyGeorgiaRekrutiert
Kailera Clinical SiteAlbanyNew YorkRekrutiert
Kailera Clinical SiteBrownsvilleTexasRekrutiert
Kailera Clinical SiteChicagoIllinoisRekrutiert
Kailera Clinical SiteEast GreenwichRhode IslandRekrutiert
Kailera Clinical SiteFarmington HillsMichiganRekrutiert
Kailera Clinical SiteGlendaleArizonaRekrutiert
Kailera Clinical SiteHamdenConnecticutRekrutiert
Kailera Clinical SiteLas VegasNevadaRekrutiert
Kailera Clinical SiteLittle RockArkansasRekrutiert
Kailera Clinical SiteManassasVirginiaRekrutiert
Kailera Clinical SiteMissoulaMontanaRekrutiert
Kailera Clinical SiteMorehead CityNorth CarolinaRekrutiert
Kailera Clinical SiteMorrisvilleNorth CarolinaRekrutiert
Kailera Clinical SiteNewtonKansasRekrutiert
Kailera Clinical SiteNormanOklahomaRekrutiert
Kailera Clinical SiteNorth CharlestonSouth CarolinaRekrutiert
Kailera Clinical SiteNorthridgeCaliforniaRekrutiert

9 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 1. September 2026

    Studienzentrum hinzugefügt

    6 sites added (59 total)

    5359

Register: ClinicalTrials.gov · NCT########

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