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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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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.

שלב 3דרושים 1,200 משתתפים59 אתרים5 מדינות

קטגוריות

אנדוקריני ומטבולי100%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

  • Obesity

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהDOUBLE (2)
גיוסדרושים 1,200 משתתפים

נותן חסות ושותפים

  • Kailera נותן חסות

זרועות והתערבויות

  • 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.

התערבויות

  • תרופה Placebo

    SC Injection

  • תרופה Ribupatide

    SC Injection

  • תרופה Semaglutide

    SC Injection

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Percent Change From Baseline in Body Weight at Week 76

    מסגרת זמן Baseline, Week 76

  2. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  3. מדד תוצאה משני

    Change From Baseline in Waist Circumference

    מסגרת זמן Baseline, Week 76

  4. מדד תוצאה משני

    Change From Baseline in Absolute Body Weight

    מסגרת זמן Baseline, Week 76

  5. מדד תוצאה משני

    Percentage of Participants with ≥5% Reduction in Body Weight

    מסגרת זמן Baseline, Week 76

  6. מדד תוצאה משני

    Change From Baseline in Systolic Blood Pressure (SBP)

    מסגרת זמן Baseline, Week 76

  7. מדד תוצאה משני

    Percent Change From Baseline in Fasting Triglycerides

    מסגרת זמן Baseline, Week 76

  8. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  9. מדד תוצאה משני

    Percent Change From Baseline in Fasting Non-HDL-cholesterol

    מסגרת זמן Baseline, Week 76

  10. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  11. מדד תוצאה משני

    Percentage of Participants with ≥30% Reduction in Body Weight

    מסגרת זמן Baseline, Week 76

  12. מדד תוצאה משני

    Change From Baseline in Body Mass Index (BMI)

    מסגרת זמן Baseline, Week 76

  13. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  14. מדד תוצאה משני

    Change From Baseline in CoEQ Positive Mood Score

    מסגרת זמן Baseline, Week 76

  15. מדד תוצאה משני

    Change From Baseline in CoEQ Craving for Sweets Score

    מסגרת זמן Baseline, Week 76

  16. מדד תוצאה משני

    Change From Baseline in CoEQ Craving for Savory Food Score

    מסגרת זמן Baseline, Week 76

  17. מדד תוצאה משני

    Change From Baseline in CoEQ Hunger Score

    מסגרת זמן Baseline, Week 76

  18. מדד תוצאה משני

    Change From Baseline in CoEQ Satiety Score

    מסגרת זמן Baseline, Week 76

  19. מדד תוצאה משני

    Change From Baseline in CoEQ Combined Score

    מסגרת זמן Baseline, Week 76

  20. מדד תוצאה משני

    Change From Baseline in Food Noise Questionnaire (FNQ) Score

    מסגרת זמן Baseline, Week 76

  21. מדד תוצאה משני

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

    מסגרת זמן Day 1 up to Week 80

  22. מדד תוצאה משני

    Number of Participants With Anti-drug Antibodies (ADAs)

    מסגרת זמן Up to Week 80

  23. מדד תוצאה משני

    Number of Participants With Neutralizing Antibodies (Nabs)

    מסגרת זמן Up to Week 80

  24. מדד תוצאה משני

    Plasma Concentrations of Ribupatide

    מסגרת זמן Up to Week 76

תאריכים

תאריך התחלה30 בדצמבר 2025 (בפועל)
סיום ראשוני1 במרץ 2028 (משוער)
סיום1 באפריל 2028 (משוער)
פורסם לראשונה16 בדצמבר 2025 (בפועל)
עודכן לאחרונה1 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהאוגוסט 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

59 אתרים מגייסים

Australia

מתקןעירמדינה או אזורמצב
Kailera Clinical SiteBlacktownNew South Walesמגייס
Kailera Clinical SiteBruceAustralian Capital Territoryמגייס
Kailera Clinical SiteCamberwellVictoriaמגייס
Kailera Clinical SiteHerstonQueenslandמגייס
Kailera Clinical SiteKanwalNew South Walesמגייס
Kailera Clinical SiteMorayfieldQueenslandמגייס
Kailera Clinical SiteSouth BrisbaneQueenslandמגייס

Bulgaria

מתקןעירמדינה או אזורמצב
Kailera Clinical SiteMontanaמגייס
Kailera Clinical SitePlevenPleven Provinceמגייס
Kailera Clinical SitePlovdivPlovdiv Provinceמגייס
Kailera Clinical SiteSofiaSofiaמגייס
Kailera Clinical SiteSofiaמגייס
Kailera Clinical SiteSofiaמגייס
Kailera Clinical SiteSofiaSofiaמגייס
Kailera Clinical SiteStara Zagoraמגייס
Kailera Clinical SiteVarnaVarna Provinceמגייס

Poland

מתקןעירמדינה או אזורמצב
Kailera Clinical SiteBydgoszczמגייס
Kailera Clinical SiteChorzówSilesian Voivodeshipמגייס
Kailera Clinical SiteGdyniaמגייס
Kailera Clinical SiteGdyniaPomeranian Voivodeshipמגייס
Kailera Clinical SiteKielceŚwiętokrzyskie Voivodeshipמגייס
Kailera Clinical SiteKrakowLesser Poland Voivodeshipמגייס
Kailera Clinical SiteWarsawMasovian Voivodeshipמגייס
Kailera Clinical SiteWroclawמגייס

United Kingdom

מתקןעירמדינה או אזורמצב
Kailera Clinical SiteExeterDevonמגייס
Kailera Clinical SiteGlasgowGlasgow Cityמגייס
Kailera Clinical SiteLeicesterLeicestershireמגייס
Kailera Clinical SiteLondonGreater Londonמגייס
Kailera Clinical SiteLondonGreater Londonמגייס
Kailera Clinical SiteRotherhamSouth Yorkshireמגייס
Kailera Clinical SiteTorquayDevonמגייס
Kailera Clinical SiteWeymouthDorsetמגייס

United States

מתקןעירמדינה או אזורמצב
Kailera Clinical SiteAlbanyGeorgiaמגייס
Kailera Clinical SiteAlbanyNew Yorkמגייס
Kailera Clinical SiteBrownsvilleTexasמגייס
Kailera Clinical SiteChicagoIllinoisמגייס
Kailera Clinical SiteEast GreenwichRhode Islandמגייס
Kailera Clinical SiteFarmington HillsMichiganמגייס
Kailera Clinical SiteGlendaleArizonaמגייס
Kailera Clinical SiteHamdenConnecticutמגייס
Kailera Clinical SiteLas VegasNevadaמגייס
Kailera Clinical SiteLittle RockArkansasמגייס
Kailera Clinical SiteManassasVirginiaמגייס
Kailera Clinical SiteMissoulaMontanaמגייס
Kailera Clinical SiteMorehead CityNorth Carolinaמגייס
Kailera Clinical SiteMorrisvilleNorth Carolinaמגייס
Kailera Clinical SiteNewtonKansasמגייס
Kailera Clinical SiteNormanOklahomaמגייס
Kailera Clinical SiteNorth CharlestonSouth Carolinaמגייס
Kailera Clinical SiteNorthridgeCaliforniaמגייס

9 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 1 בספטמבר 2026

    אתר נוסף

    6 sites added (59 total)

    5359

מרשם: ClinicalTrials.gov · NCT########

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