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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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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)

Phase 31.156 Teilnehmende gesucht167 Studienzentren11 Länder

Kategorien

Endokrin und metabolisch100%

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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.

Zusammenfassung

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)

Erkrankungen

  • Obesity With Diabetes
  • Overweight With Diabetes

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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.

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)
Teilnahme1.156 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.

  • 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.

Interventionen

  • Arzneimittel Placebo

    SC Injection

  • Arzneimittel Ribupatide

    SC Injection

Endpunkte

  1. Primärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  2. Primärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  3. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  4. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  5. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  6. Sekundärer Endpunkt

    Change From Baseline in Waist Circumference

    Zeitrahmen Baseline, Week 76

  7. Sekundärer Endpunkt

    Change From Baseline in Absolute Body Weight

    Zeitrahmen Baseline, Week 76

  8. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  9. Sekundärer Endpunkt

    Change From Baseline in Fasting Blood Glucose

    Zeitrahmen Baseline, Week 76

  10. Sekundärer Endpunkt

    Change From Baseline in Systolic Blood Pressure (SBP)

    Zeitrahmen Baseline, Week 76

  11. Sekundärer Endpunkt

    Percent Change From Baseline in Fasting Triglycerides

    Zeitrahmen Baseline, Week 76

  12. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  13. Sekundärer Endpunkt

    Percent Change From Baseline in Fasting Non-HDL-cholesterol

    Zeitrahmen Baseline, Week 76

  14. 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

  15. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  16. Sekundärer Endpunkt

    Percentage of Participants with ≥30% Reduction in Body Weight

    Zeitrahmen Baseline, Week 76

  17. Sekundärer Endpunkt

    Change From Baseline in BMI

    Zeitrahmen Baseline, Week 76

  18. Sekundärer Endpunkt

    Percentage of Participants with HbA1c <5.7%

    Zeitrahmen Baseline, Week 76

  19. Sekundärer Endpunkt

    Change From Baseline in Diastolic Blood Pressure (DBP)

    Zeitrahmen Baseline, Week 76

  20. Sekundärer Endpunkt

    Percent Change From Baseline in Fasting Total Cholesterol

    Zeitrahmen Baseline, Week 76

  21. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  22. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  23. Sekundärer Endpunkt

    Percent Change From Baseline in Fasting Insulin

    Zeitrahmen Baseline, Week 76

  24. Sekundärer Endpunkt

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

    Zeitrahmen Baseline, Week 76

  25. Sekundärer Endpunkt

    Change From Baseline in CoEQ Positive Mood Score

    Zeitrahmen Baseline, Week 76

  26. Sekundärer Endpunkt

    Change From Baseline in CoEQ Craving for Sweets Score

    Zeitrahmen Baseline, Week 76

  27. Sekundärer Endpunkt

    Change From Baseline in CoEQ Craving for Savory Food Score

    Zeitrahmen Baseline, Week 76

  28. Sekundärer Endpunkt

    Change From Baseline in CoEQ Hunger Score

    Zeitrahmen Baseline, Week 76

  29. Sekundärer Endpunkt

    Change From Baseline in CoEQ Satiety Score

    Zeitrahmen Baseline, Week 76

  30. Sekundärer Endpunkt

    Change From Baseline in CoEQ Combined Score

    Zeitrahmen Baseline, Week 76

  31. Sekundärer Endpunkt

    Change From Baseline in Food Noise Questionnaire (FNQ) Score

    Zeitrahmen Baseline, Week 76

  32. Sekundärer Endpunkt

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

    Zeitrahmen Day 1 up to Week 80

  33. Sekundärer Endpunkt

    Number of Participants With Anti-drug Antibodies (ADAs)

    Zeitrahmen Up to Week 80

  34. Sekundärer Endpunkt

    Number of Participants With Neutralizing Antibodies (Nabs)

    Zeitrahmen Up to Week 80

  35. Sekundärer Endpunkt

    Plasma Concentrations of Ribupatide

    Zeitrahmen Up to Week 76

Daten

Startdatum12. Januar 2026 (tatsächlich)
Primärer Abschluss27. März 2028 (geschätzt)
Abschluss24. April 2028 (geschätzt)
Erstveröffentlichung16. Dezember 2025 (tatsächlich)
Zuletzt aktualisiert3. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtSeptember 2026

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

Standorte

165 Studienzentren rekrutieren

Argentina

EinrichtungStadtBundesland oder RegionStatus
Kailera Clinical SiteBuenos AiresRekrutiert
Kailera Clinical SiteBuenos AiresRekrutiert
Kailera Clinical SiteBuenos AiresRekrutiert
Kailera Clinical SiteBuenos AiresRekrutiert
Kailera Clinical SiteCiudad Autonoma de Buenos AiresBuenos AiresRekrutiert
Kailera Clinical SiteCórdobaRekrutiert
Kailera Clinical SiteCórdobaRekrutiert
Kailera Clinical SiteGodoy CruzMendoza ProvinceRekrutiert
Kailera Clinical SiteLa PlataBuenos AiresRekrutiert
Kailera Clinical SiteMar del PlataBuenos AiresRekrutiert
Kailera Clinical SiteRosarioSanta Fe ProvinceRekrutiert
Kailera Clinical SiteRosarioSante FeRekrutiert
Kailera Clinical SiteSan Nicolás de los ArroyosBuenos AiresRekrutiert
Kailera Clinical SiteZárateBuenos AiresRekrutiert

Australia

EinrichtungStadtBundesland oder RegionStatus
Kailera Clinical SiteBlacktownNew South WalesRekrutiert
Kailera Clinical SiteBruceAustralian Capital TerritoryRekrutiert
Kailera Clinical SiteCamberwellVictoriaRekrutiert
Kailera Clinical SiteCharlestownNew South WalesRekrutiert
Kailera Clinical SiteHerstonQueenslandRekrutiert
Kailera Clinical SiteKanwalNew South WalesRekrutiert
Kailera Clinical SiteLeichhardtNew South WalesRekrutiert
Kailera Clinical SiteMelbourneVictoriaRekrutiert
Kailera Clinical SiteMorayfieldQueenslandRekrutiert
Kailera Clinical SitePenrithNew South WalesRekrutiert
Kailera Clinical SiteSouth BrisbaneRekrutiert
Kailera Clinical SiteSydneyNew South WalesRekrutiert
Kailera Clinical SiteSydneyNew South WalesRekrutiert
Kailera Clinical SiteWollongongNew South WalesRekrutiert

Bulgaria

EinrichtungStadtBundesland oder RegionStatus
Kailera Clinical SiteKyustendilKyustendil ProvinceRekrutiert
Kailera Clinical SiteMontanaRekrutiert
Kailera Clinical SitePlevenPleven ProvinceRekrutiert
Kailera Clinical SitePlovdivPlovdiv ProvinceRekrutiert
Kailera Clinical SiteRousseRuse ProvinceRekrutiert
Kailera Clinical SiteSofiaSofiaRekrutiert
Kailera Clinical SiteSofiaSofiaRekrutiert
Kailera Clinical SiteSofiaSofiaRekrutiert
Kailera Clinical SiteStara ZagoraStara Zagora ProvinceRekrutiert
Kailera Clinical SiteVarnaVarna ProvinceRekrutiert

Czechia

EinrichtungStadtBundesland oder RegionStatus
Kailera Clinical SiteBohnicePragueRekrutiert
Kailera Clinical SiteBrandýs nad LabemCentral BohemiaRekrutiert
Kailera Clinical SiteBrnoSouth MoravianRekrutiert
Kailera Clinical SiteHodonínRekrutiert
Kailera Clinical SiteHolešovZlínRekrutiert
Kailera Clinical SiteNáchodHradec Králové RegionRekrutiert
Kailera Clinical SiteOlomoucRekrutiert
Kailera Clinical SitePardubiceRekrutiert
Kailera Clinical SitePragueRekrutiert
Kailera Clinical SitePraguePragueRekrutiert
Kailera Clinical SiteTrutnovHradec Králové RegionRekrutiert
Kailera Clinical SiteUherské HradištěRekrutiert

117 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 3. September 2026

    Studienzentrum hinzugefügt

    4 sites added (167 total)

    163167

  2. 1. September 2026

    Studienzentrum hinzugefügt

    47 sites added (163 total)

    116163

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

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