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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

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 placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)

שלב 3דרושים 1,156 משתתפים167 אתרים11 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 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.

תקציר

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)

מצבים רפואיים

  • Obesity With Diabetes
  • Overweight With Diabetes

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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.

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 1,156 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.

  • 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.

התערבויות

  • תרופה Placebo

    SC Injection

  • תרופה Ribupatide

    SC Injection

מדדי תוצאה

  1. מדד תוצאה ראשוני

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

    מסגרת זמן Baseline, Week 76

  2. מדד תוצאה ראשוני

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

    מסגרת זמן Baseline, Week 76

  3. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  4. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  5. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  6. מדד תוצאה משני

    Change From Baseline in Waist Circumference

    מסגרת זמן Baseline, Week 76

  7. מדד תוצאה משני

    Change From Baseline in Absolute Body Weight

    מסגרת זמן Baseline, Week 76

  8. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  9. מדד תוצאה משני

    Change From Baseline in Fasting Blood Glucose

    מסגרת זמן Baseline, Week 76

  10. מדד תוצאה משני

    Change From Baseline in Systolic Blood Pressure (SBP)

    מסגרת זמן Baseline, Week 76

  11. מדד תוצאה משני

    Percent Change From Baseline in Fasting Triglycerides

    מסגרת זמן Baseline, Week 76

  12. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  13. מדד תוצאה משני

    Percent Change From Baseline in Fasting Non-HDL-cholesterol

    מסגרת זמן Baseline, Week 76

  14. 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

  15. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  16. מדד תוצאה משני

    Percentage of Participants with ≥30% Reduction in Body Weight

    מסגרת זמן Baseline, Week 76

  17. מדד תוצאה משני

    Change From Baseline in BMI

    מסגרת זמן Baseline, Week 76

  18. מדד תוצאה משני

    Percentage of Participants with HbA1c <5.7%

    מסגרת זמן Baseline, Week 76

  19. מדד תוצאה משני

    Change From Baseline in Diastolic Blood Pressure (DBP)

    מסגרת זמן Baseline, Week 76

  20. מדד תוצאה משני

    Percent Change From Baseline in Fasting Total Cholesterol

    מסגרת זמן Baseline, Week 76

  21. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  22. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  23. מדד תוצאה משני

    Percent Change From Baseline in Fasting Insulin

    מסגרת זמן Baseline, Week 76

  24. מדד תוצאה משני

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

    מסגרת זמן Baseline, Week 76

  25. מדד תוצאה משני

    Change From Baseline in CoEQ Positive Mood Score

    מסגרת זמן Baseline, Week 76

  26. מדד תוצאה משני

    Change From Baseline in CoEQ Craving for Sweets Score

    מסגרת זמן Baseline, Week 76

  27. מדד תוצאה משני

    Change From Baseline in CoEQ Craving for Savory Food Score

    מסגרת זמן Baseline, Week 76

  28. מדד תוצאה משני

    Change From Baseline in CoEQ Hunger Score

    מסגרת זמן Baseline, Week 76

  29. מדד תוצאה משני

    Change From Baseline in CoEQ Satiety Score

    מסגרת זמן Baseline, Week 76

  30. מדד תוצאה משני

    Change From Baseline in CoEQ Combined Score

    מסגרת זמן Baseline, Week 76

  31. מדד תוצאה משני

    Change From Baseline in Food Noise Questionnaire (FNQ) Score

    מסגרת זמן Baseline, Week 76

  32. מדד תוצאה משני

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

    מסגרת זמן Day 1 up to Week 80

  33. מדד תוצאה משני

    Number of Participants With Anti-drug Antibodies (ADAs)

    מסגרת זמן Up to Week 80

  34. מדד תוצאה משני

    Number of Participants With Neutralizing Antibodies (Nabs)

    מסגרת זמן Up to Week 80

  35. מדד תוצאה משני

    Plasma Concentrations of Ribupatide

    מסגרת זמן Up to Week 76

תאריכים

תאריך התחלה12 בינואר 2026 (בפועל)
סיום ראשוני27 במרץ 2028 (משוער)
סיום24 באפריל 2028 (משוער)
פורסם לראשונה16 בדצמבר 2025 (בפועל)
עודכן לאחרונה3 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהספטמבר 2026

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

מיקומים

165 אתרים מגייסים

Argentina

מתקןעירמדינה או אזורמצב
Kailera Clinical SiteBuenos Airesמגייס
Kailera Clinical SiteBuenos Airesמגייס
Kailera Clinical SiteBuenos Airesמגייס
Kailera Clinical SiteBuenos Airesמגייס
Kailera Clinical SiteCiudad Autonoma de Buenos AiresBuenos Airesמגייס
Kailera Clinical SiteCórdobaמגייס
Kailera Clinical SiteCórdobaמגייס
Kailera Clinical SiteGodoy CruzMendoza Provinceמגייס
Kailera Clinical SiteLa PlataBuenos Airesמגייס
Kailera Clinical SiteMar del PlataBuenos Airesמגייס
Kailera Clinical SiteRosarioSanta Fe Provinceמגייס
Kailera Clinical SiteRosarioSante Feמגייס
Kailera Clinical SiteSan Nicolás de los ArroyosBuenos Airesמגייס
Kailera Clinical SiteZárateBuenos Airesמגייס

Australia

מתקןעירמדינה או אזורמצב
Kailera Clinical SiteBlacktownNew South Walesמגייס
Kailera Clinical SiteBruceAustralian Capital Territoryמגייס
Kailera Clinical SiteCamberwellVictoriaמגייס
Kailera Clinical SiteCharlestownNew South Walesמגייס
Kailera Clinical SiteHerstonQueenslandמגייס
Kailera Clinical SiteKanwalNew South Walesמגייס
Kailera Clinical SiteLeichhardtNew South Walesמגייס
Kailera Clinical SiteMelbourneVictoriaמגייס
Kailera Clinical SiteMorayfieldQueenslandמגייס
Kailera Clinical SitePenrithNew South Walesמגייס
Kailera Clinical SiteSouth Brisbaneמגייס
Kailera Clinical SiteSydneyNew South Walesמגייס
Kailera Clinical SiteSydneyNew South Walesמגייס
Kailera Clinical SiteWollongongNew South Walesמגייס

Bulgaria

מתקןעירמדינה או אזורמצב
Kailera Clinical SiteKyustendilKyustendil Provinceמגייס
Kailera Clinical SiteMontanaמגייס
Kailera Clinical SitePlevenPleven Provinceמגייס
Kailera Clinical SitePlovdivPlovdiv Provinceמגייס
Kailera Clinical SiteRousseRuse Provinceמגייס
Kailera Clinical SiteSofiaSofiaמגייס
Kailera Clinical SiteSofiaSofiaמגייס
Kailera Clinical SiteSofiaSofiaמגייס
Kailera Clinical SiteStara ZagoraStara Zagora Provinceמגייס
Kailera Clinical SiteVarnaVarna Provinceמגייס

Czechia

מתקןעירמדינה או אזורמצב
Kailera Clinical SiteBohnicePragueמגייס
Kailera Clinical SiteBrandýs nad LabemCentral Bohemiaמגייס
Kailera Clinical SiteBrnoSouth Moravianמגייס
Kailera Clinical SiteHodonínמגייס
Kailera Clinical SiteHolešovZlínמגייס
Kailera Clinical SiteNáchodHradec Králové Regionמגייס
Kailera Clinical SiteOlomoucמגייס
Kailera Clinical SitePardubiceמגייס
Kailera Clinical SitePragueמגייס
Kailera Clinical SitePraguePragueמגייס
Kailera Clinical SiteTrutnovHradec Králové Regionמגייס
Kailera Clinical SiteUherské Hradištěמגייס

117 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 3 בספטמבר 2026

    אתר נוסף

    4 sites added (167 total)

    163167

  2. 1 בספטמבר 2026

    אתר נוסף

    47 sites added (163 total)

    116163

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

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