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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

RecruitingTaking participants now, according to the registry record.
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In brief

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 sought59 sites5 countries

Categories

Endocrine & metabolic100%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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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.

Summary

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.

Conditions

  • Obesity

Eligibility

SexAll
Ages18 Years – No maximum
Healthy volunteersNo

Eligibility as written in the registry

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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhasePhase 3
AllocationRandomised
Intervention modelPARALLEL
Primary purposeTREATMENT
MaskingDOUBLE (2)
Enrolment1,200 participants sought

Sponsor and collaborators

  • Kailera Sponsor

Arms and 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

  • Drug Placebo

    SC Injection

  • Drug Ribupatide

    SC Injection

  • Drug Semaglutide

    SC Injection

Outcome measures

  1. Primary outcome

    Percent Change From Baseline in Body Weight at Week 76

    Time frame Baseline, Week 76

  2. Secondary outcome

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

    Time frame Baseline, Week 76

  3. Secondary outcome

    Change From Baseline in Waist Circumference

    Time frame Baseline, Week 76

  4. Secondary outcome

    Change From Baseline in Absolute Body Weight

    Time frame Baseline, Week 76

  5. Secondary outcome

    Percentage of Participants with ≥5% Reduction in Body Weight

    Time frame Baseline, Week 76

  6. Secondary outcome

    Change From Baseline in Systolic Blood Pressure (SBP)

    Time frame Baseline, Week 76

  7. Secondary outcome

    Percent Change From Baseline in Fasting Triglycerides

    Time frame Baseline, Week 76

  8. Secondary outcome

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

    Time frame Baseline, Week 76

  9. Secondary outcome

    Percent Change From Baseline in Fasting Non-HDL-cholesterol

    Time frame Baseline, Week 76

  10. Secondary outcome

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

    Time frame Baseline, Week 76

  11. Secondary outcome

    Percentage of Participants with ≥30% Reduction in Body Weight

    Time frame Baseline, Week 76

  12. Secondary outcome

    Change From Baseline in Body Mass Index (BMI)

    Time frame Baseline, Week 76

  13. Secondary outcome

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

    Time frame Baseline, Week 76

  14. Secondary outcome

    Change From Baseline in CoEQ Positive Mood Score

    Time frame Baseline, Week 76

  15. Secondary outcome

    Change From Baseline in CoEQ Craving for Sweets Score

    Time frame Baseline, Week 76

  16. Secondary outcome

    Change From Baseline in CoEQ Craving for Savory Food Score

    Time frame Baseline, Week 76

  17. Secondary outcome

    Change From Baseline in CoEQ Hunger Score

    Time frame Baseline, Week 76

  18. Secondary outcome

    Change From Baseline in CoEQ Satiety Score

    Time frame Baseline, Week 76

  19. Secondary outcome

    Change From Baseline in CoEQ Combined Score

    Time frame Baseline, Week 76

  20. Secondary outcome

    Change From Baseline in Food Noise Questionnaire (FNQ) Score

    Time frame Baseline, Week 76

  21. Secondary outcome

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

    Time frame Day 1 up to Week 80

  22. Secondary outcome

    Number of Participants With Anti-drug Antibodies (ADAs)

    Time frame Up to Week 80

  23. Secondary outcome

    Number of Participants With Neutralizing Antibodies (Nabs)

    Time frame Up to Week 80

  24. Secondary outcome

    Plasma Concentrations of Ribupatide

    Time frame Up to Week 76

Dates

Start dateDecember 30, 2025 (actual)
Primary completionMarch 1, 2028 (estimated)
CompletionApril 1, 2028 (estimated)
First postedDecember 16, 2025 (actual)
Last updatedSeptember 1, 2026
Results postedNot stated in the registry record
Status last verifiedAugust 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

59 sites are recruiting

Australia

FacilityCityState or regionStatus
Kailera Clinical SiteBlacktownNew South WalesRecruiting
Kailera Clinical SiteBruceAustralian Capital TerritoryRecruiting
Kailera Clinical SiteCamberwellVictoriaRecruiting
Kailera Clinical SiteHerstonQueenslandRecruiting
Kailera Clinical SiteKanwalNew South WalesRecruiting
Kailera Clinical SiteMorayfieldQueenslandRecruiting
Kailera Clinical SiteSouth BrisbaneQueenslandRecruiting

Bulgaria

FacilityCityState or regionStatus
Kailera Clinical SiteMontanaRecruiting
Kailera Clinical SitePlevenPleven ProvinceRecruiting
Kailera Clinical SitePlovdivPlovdiv ProvinceRecruiting
Kailera Clinical SiteSofiaSofiaRecruiting
Kailera Clinical SiteSofiaRecruiting
Kailera Clinical SiteSofiaRecruiting
Kailera Clinical SiteSofiaSofiaRecruiting
Kailera Clinical SiteStara ZagoraRecruiting
Kailera Clinical SiteVarnaVarna ProvinceRecruiting

Poland

FacilityCityState or regionStatus
Kailera Clinical SiteBydgoszczRecruiting
Kailera Clinical SiteChorzówSilesian VoivodeshipRecruiting
Kailera Clinical SiteGdyniaRecruiting
Kailera Clinical SiteGdyniaPomeranian VoivodeshipRecruiting
Kailera Clinical SiteKielceŚwiętokrzyskie VoivodeshipRecruiting
Kailera Clinical SiteKrakowLesser Poland VoivodeshipRecruiting
Kailera Clinical SiteWarsawMasovian VoivodeshipRecruiting
Kailera Clinical SiteWroclawRecruiting

United Kingdom

FacilityCityState or regionStatus
Kailera Clinical SiteExeterDevonRecruiting
Kailera Clinical SiteGlasgowGlasgow CityRecruiting
Kailera Clinical SiteLeicesterLeicestershireRecruiting
Kailera Clinical SiteLondonGreater LondonRecruiting
Kailera Clinical SiteLondonGreater LondonRecruiting
Kailera Clinical SiteRotherhamSouth YorkshireRecruiting
Kailera Clinical SiteTorquayDevonRecruiting
Kailera Clinical SiteWeymouthDorsetRecruiting

United States

FacilityCityState or regionStatus
Kailera Clinical SiteAlbanyGeorgiaRecruiting
Kailera Clinical SiteAlbanyNew YorkRecruiting
Kailera Clinical SiteBrownsvilleTexasRecruiting
Kailera Clinical SiteChicagoIllinoisRecruiting
Kailera Clinical SiteEast GreenwichRhode IslandRecruiting
Kailera Clinical SiteFarmington HillsMichiganRecruiting
Kailera Clinical SiteGlendaleArizonaRecruiting
Kailera Clinical SiteHamdenConnecticutRecruiting
Kailera Clinical SiteLas VegasNevadaRecruiting
Kailera Clinical SiteLittle RockArkansasRecruiting
Kailera Clinical SiteManassasVirginiaRecruiting
Kailera Clinical SiteMissoulaMontanaRecruiting
Kailera Clinical SiteMorehead CityNorth CarolinaRecruiting
Kailera Clinical SiteMorrisvilleNorth CarolinaRecruiting
Kailera Clinical SiteNewtonKansasRecruiting
Kailera Clinical SiteNormanOklahomaRecruiting
Kailera Clinical SiteNorth CharlestonSouth CarolinaRecruiting
Kailera Clinical SiteNorthridgeCaliforniaRecruiting

9 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

  1. September 1, 2026

    Site added

    6 sites added (59 total)

    5359

Registry: ClinicalTrials.gov · NCT########

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