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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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.

المرحلة 3مطلوب 1,200 مشارك59 موقعاً5 دول

الفئات

الغدد الصمّاء والأيض100%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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.

الحالات

  • Obesity

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةDOUBLE (2)
التجنيدمطلوب 1,200 مشارك

الجهة الراعية والمتعاونون

  • Kailera الجهة الراعية

الأذرع والتدخلات

  • 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.

التدخلات

  • دواء Placebo

    SC Injection

  • دواء Ribupatide

    SC Injection

  • دواء Semaglutide

    SC Injection

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Percent Change From Baseline in Body Weight at Week 76

    الإطار الزمني Baseline, Week 76

  2. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  3. مقياس النتيجة الثانوي

    Change From Baseline in Waist Circumference

    الإطار الزمني Baseline, Week 76

  4. مقياس النتيجة الثانوي

    Change From Baseline in Absolute Body Weight

    الإطار الزمني Baseline, Week 76

  5. مقياس النتيجة الثانوي

    Percentage of Participants with ≥5% Reduction in Body Weight

    الإطار الزمني Baseline, Week 76

  6. مقياس النتيجة الثانوي

    Change From Baseline in Systolic Blood Pressure (SBP)

    الإطار الزمني Baseline, Week 76

  7. مقياس النتيجة الثانوي

    Percent Change From Baseline in Fasting Triglycerides

    الإطار الزمني Baseline, Week 76

  8. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  9. مقياس النتيجة الثانوي

    Percent Change From Baseline in Fasting Non-HDL-cholesterol

    الإطار الزمني Baseline, Week 76

  10. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  11. مقياس النتيجة الثانوي

    Percentage of Participants with ≥30% Reduction in Body Weight

    الإطار الزمني Baseline, Week 76

  12. مقياس النتيجة الثانوي

    Change From Baseline in Body Mass Index (BMI)

    الإطار الزمني Baseline, Week 76

  13. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  14. مقياس النتيجة الثانوي

    Change From Baseline in CoEQ Positive Mood Score

    الإطار الزمني Baseline, Week 76

  15. مقياس النتيجة الثانوي

    Change From Baseline in CoEQ Craving for Sweets Score

    الإطار الزمني Baseline, Week 76

  16. مقياس النتيجة الثانوي

    Change From Baseline in CoEQ Craving for Savory Food Score

    الإطار الزمني Baseline, Week 76

  17. مقياس النتيجة الثانوي

    Change From Baseline in CoEQ Hunger Score

    الإطار الزمني Baseline, Week 76

  18. مقياس النتيجة الثانوي

    Change From Baseline in CoEQ Satiety Score

    الإطار الزمني Baseline, Week 76

  19. مقياس النتيجة الثانوي

    Change From Baseline in CoEQ Combined Score

    الإطار الزمني Baseline, Week 76

  20. مقياس النتيجة الثانوي

    Change From Baseline in Food Noise Questionnaire (FNQ) Score

    الإطار الزمني Baseline, Week 76

  21. مقياس النتيجة الثانوي

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

    الإطار الزمني Day 1 up to Week 80

  22. مقياس النتيجة الثانوي

    Number of Participants With Anti-drug Antibodies (ADAs)

    الإطار الزمني Up to Week 80

  23. مقياس النتيجة الثانوي

    Number of Participants With Neutralizing Antibodies (Nabs)

    الإطار الزمني Up to Week 80

  24. مقياس النتيجة الثانوي

    Plasma Concentrations of Ribupatide

    الإطار الزمني Up to Week 76

التواريخ

تاريخ البدء30 ديسمبر 2025 (فعلي)
الإتمام الأولي1 مارس 2028 (تقديري)
الإتمام1 أبريل 2028 (تقديري)
أول نشر16 ديسمبر 2025 (فعلي)
آخر تحديث1 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةأغسطس 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

59 موقعاً قيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Kailera Clinical SiteBlacktownNew South Walesقيد التجنيد
Kailera Clinical SiteBruceAustralian Capital Territoryقيد التجنيد
Kailera Clinical SiteCamberwellVictoriaقيد التجنيد
Kailera Clinical SiteHerstonQueenslandقيد التجنيد
Kailera Clinical SiteKanwalNew South Walesقيد التجنيد
Kailera Clinical SiteMorayfieldQueenslandقيد التجنيد
Kailera Clinical SiteSouth BrisbaneQueenslandقيد التجنيد

Bulgaria

المنشأةالمدينةالولاية أو المنطقةالحالة
Kailera Clinical SiteMontanaقيد التجنيد
Kailera Clinical SitePlevenPleven Provinceقيد التجنيد
Kailera Clinical SitePlovdivPlovdiv Provinceقيد التجنيد
Kailera Clinical SiteSofiaSofiaقيد التجنيد
Kailera Clinical SiteSofiaقيد التجنيد
Kailera Clinical SiteSofiaقيد التجنيد
Kailera Clinical SiteSofiaSofiaقيد التجنيد
Kailera Clinical SiteStara Zagoraقيد التجنيد
Kailera Clinical SiteVarnaVarna Provinceقيد التجنيد

Poland

المنشأةالمدينةالولاية أو المنطقةالحالة
Kailera Clinical SiteBydgoszczقيد التجنيد
Kailera Clinical SiteChorzówSilesian Voivodeshipقيد التجنيد
Kailera Clinical SiteGdyniaقيد التجنيد
Kailera Clinical SiteGdyniaPomeranian Voivodeshipقيد التجنيد
Kailera Clinical SiteKielceŚwiętokrzyskie Voivodeshipقيد التجنيد
Kailera Clinical SiteKrakowLesser Poland Voivodeshipقيد التجنيد
Kailera Clinical SiteWarsawMasovian Voivodeshipقيد التجنيد
Kailera Clinical SiteWroclawقيد التجنيد

United Kingdom

المنشأةالمدينةالولاية أو المنطقةالحالة
Kailera Clinical SiteExeterDevonقيد التجنيد
Kailera Clinical SiteGlasgowGlasgow Cityقيد التجنيد
Kailera Clinical SiteLeicesterLeicestershireقيد التجنيد
Kailera Clinical SiteLondonGreater Londonقيد التجنيد
Kailera Clinical SiteLondonGreater Londonقيد التجنيد
Kailera Clinical SiteRotherhamSouth Yorkshireقيد التجنيد
Kailera Clinical SiteTorquayDevonقيد التجنيد
Kailera Clinical SiteWeymouthDorsetقيد التجنيد

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Kailera Clinical SiteAlbanyGeorgiaقيد التجنيد
Kailera Clinical SiteAlbanyNew Yorkقيد التجنيد
Kailera Clinical SiteBrownsvilleTexasقيد التجنيد
Kailera Clinical SiteChicagoIllinoisقيد التجنيد
Kailera Clinical SiteEast GreenwichRhode Islandقيد التجنيد
Kailera Clinical SiteFarmington HillsMichiganقيد التجنيد
Kailera Clinical SiteGlendaleArizonaقيد التجنيد
Kailera Clinical SiteHamdenConnecticutقيد التجنيد
Kailera Clinical SiteLas VegasNevadaقيد التجنيد
Kailera Clinical SiteLittle RockArkansasقيد التجنيد
Kailera Clinical SiteManassasVirginiaقيد التجنيد
Kailera Clinical SiteMissoulaMontanaقيد التجنيد
Kailera Clinical SiteMorehead CityNorth Carolinaقيد التجنيد
Kailera Clinical SiteMorrisvilleNorth Carolinaقيد التجنيد
Kailera Clinical SiteNewtonKansasقيد التجنيد
Kailera Clinical SiteNormanOklahomaقيد التجنيد
Kailera Clinical SiteNorth CharlestonSouth Carolinaقيد التجنيد
Kailera Clinical SiteNorthridgeCaliforniaقيد التجنيد

تُدرَج 9 مواقع إضافية في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 1 سبتمبر 2026

    أُضيف موقع

    6 sites added (59 total)

    5359

السجل: ClinicalTrials.gov · NCT########

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