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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

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

المرحلة 3مطلوب 1,156 مشاركاً167 موقعاً11 دولة

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 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.

ملخص

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)

الحالات

  • Obesity With Diabetes
  • Overweight With Diabetes

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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.

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 1,156 مشاركاً

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.

  • 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.

التدخلات

  • دواء Placebo

    SC Injection

  • دواء Ribupatide

    SC Injection

مقاييس النتائج

  1. مقياس النتيجة الأولي

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

    الإطار الزمني Baseline, Week 76

  2. مقياس النتيجة الأولي

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

    الإطار الزمني Baseline, Week 76

  3. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  4. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  5. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  6. مقياس النتيجة الثانوي

    Change From Baseline in Waist Circumference

    الإطار الزمني Baseline, Week 76

  7. مقياس النتيجة الثانوي

    Change From Baseline in Absolute Body Weight

    الإطار الزمني Baseline, Week 76

  8. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  9. مقياس النتيجة الثانوي

    Change From Baseline in Fasting Blood Glucose

    الإطار الزمني Baseline, Week 76

  10. مقياس النتيجة الثانوي

    Change From Baseline in Systolic Blood Pressure (SBP)

    الإطار الزمني Baseline, Week 76

  11. مقياس النتيجة الثانوي

    Percent Change From Baseline in Fasting Triglycerides

    الإطار الزمني Baseline, Week 76

  12. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  13. مقياس النتيجة الثانوي

    Percent Change From Baseline in Fasting Non-HDL-cholesterol

    الإطار الزمني Baseline, Week 76

  14. 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

  15. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  16. مقياس النتيجة الثانوي

    Percentage of Participants with ≥30% Reduction in Body Weight

    الإطار الزمني Baseline, Week 76

  17. مقياس النتيجة الثانوي

    Change From Baseline in BMI

    الإطار الزمني Baseline, Week 76

  18. مقياس النتيجة الثانوي

    Percentage of Participants with HbA1c <5.7%

    الإطار الزمني Baseline, Week 76

  19. مقياس النتيجة الثانوي

    Change From Baseline in Diastolic Blood Pressure (DBP)

    الإطار الزمني Baseline, Week 76

  20. مقياس النتيجة الثانوي

    Percent Change From Baseline in Fasting Total Cholesterol

    الإطار الزمني Baseline, Week 76

  21. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  22. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  23. مقياس النتيجة الثانوي

    Percent Change From Baseline in Fasting Insulin

    الإطار الزمني Baseline, Week 76

  24. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline, Week 76

  25. مقياس النتيجة الثانوي

    Change From Baseline in CoEQ Positive Mood Score

    الإطار الزمني Baseline, Week 76

  26. مقياس النتيجة الثانوي

    Change From Baseline in CoEQ Craving for Sweets Score

    الإطار الزمني Baseline, Week 76

  27. مقياس النتيجة الثانوي

    Change From Baseline in CoEQ Craving for Savory Food Score

    الإطار الزمني Baseline, Week 76

  28. مقياس النتيجة الثانوي

    Change From Baseline in CoEQ Hunger Score

    الإطار الزمني Baseline, Week 76

  29. مقياس النتيجة الثانوي

    Change From Baseline in CoEQ Satiety Score

    الإطار الزمني Baseline, Week 76

  30. مقياس النتيجة الثانوي

    Change From Baseline in CoEQ Combined Score

    الإطار الزمني Baseline, Week 76

  31. مقياس النتيجة الثانوي

    Change From Baseline in Food Noise Questionnaire (FNQ) Score

    الإطار الزمني Baseline, Week 76

  32. مقياس النتيجة الثانوي

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

    الإطار الزمني Day 1 up to Week 80

  33. مقياس النتيجة الثانوي

    Number of Participants With Anti-drug Antibodies (ADAs)

    الإطار الزمني Up to Week 80

  34. مقياس النتيجة الثانوي

    Number of Participants With Neutralizing Antibodies (Nabs)

    الإطار الزمني Up to Week 80

  35. مقياس النتيجة الثانوي

    Plasma Concentrations of Ribupatide

    الإطار الزمني Up to Week 76

التواريخ

تاريخ البدء12 يناير 2026 (فعلي)
الإتمام الأولي27 مارس 2028 (تقديري)
الإتمام24 أبريل 2028 (تقديري)
أول نشر16 ديسمبر 2025 (فعلي)
آخر تحديث3 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

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

المواقع

165 موقعاً قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Kailera Clinical SiteBuenos Airesقيد التجنيد
Kailera Clinical SiteBuenos Airesقيد التجنيد
Kailera Clinical SiteBuenos Airesقيد التجنيد
Kailera Clinical SiteBuenos Airesقيد التجنيد
Kailera Clinical SiteCiudad Autonoma de Buenos AiresBuenos Airesقيد التجنيد
Kailera Clinical SiteCórdobaقيد التجنيد
Kailera Clinical SiteCórdobaقيد التجنيد
Kailera Clinical SiteGodoy CruzMendoza Provinceقيد التجنيد
Kailera Clinical SiteLa PlataBuenos Airesقيد التجنيد
Kailera Clinical SiteMar del PlataBuenos Airesقيد التجنيد
Kailera Clinical SiteRosarioSanta Fe Provinceقيد التجنيد
Kailera Clinical SiteRosarioSante Feقيد التجنيد
Kailera Clinical SiteSan Nicolás de los ArroyosBuenos Airesقيد التجنيد
Kailera Clinical SiteZárateBuenos Airesقيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Kailera Clinical SiteBlacktownNew South Walesقيد التجنيد
Kailera Clinical SiteBruceAustralian Capital Territoryقيد التجنيد
Kailera Clinical SiteCamberwellVictoriaقيد التجنيد
Kailera Clinical SiteCharlestownNew South Walesقيد التجنيد
Kailera Clinical SiteHerstonQueenslandقيد التجنيد
Kailera Clinical SiteKanwalNew South Walesقيد التجنيد
Kailera Clinical SiteLeichhardtNew South Walesقيد التجنيد
Kailera Clinical SiteMelbourneVictoriaقيد التجنيد
Kailera Clinical SiteMorayfieldQueenslandقيد التجنيد
Kailera Clinical SitePenrithNew South Walesقيد التجنيد
Kailera Clinical SiteSouth Brisbaneقيد التجنيد
Kailera Clinical SiteSydneyNew South Walesقيد التجنيد
Kailera Clinical SiteSydneyNew South Walesقيد التجنيد
Kailera Clinical SiteWollongongNew South Walesقيد التجنيد

Bulgaria

المنشأةالمدينةالولاية أو المنطقةالحالة
Kailera Clinical SiteKyustendilKyustendil Provinceقيد التجنيد
Kailera Clinical SiteMontanaقيد التجنيد
Kailera Clinical SitePlevenPleven Provinceقيد التجنيد
Kailera Clinical SitePlovdivPlovdiv Provinceقيد التجنيد
Kailera Clinical SiteRousseRuse Provinceقيد التجنيد
Kailera Clinical SiteSofiaSofiaقيد التجنيد
Kailera Clinical SiteSofiaSofiaقيد التجنيد
Kailera Clinical SiteSofiaSofiaقيد التجنيد
Kailera Clinical SiteStara ZagoraStara Zagora Provinceقيد التجنيد
Kailera Clinical SiteVarnaVarna Provinceقيد التجنيد

Czechia

المنشأةالمدينةالولاية أو المنطقةالحالة
Kailera Clinical SiteBohnicePragueقيد التجنيد
Kailera Clinical SiteBrandýs nad LabemCentral Bohemiaقيد التجنيد
Kailera Clinical SiteBrnoSouth Moravianقيد التجنيد
Kailera Clinical SiteHodonínقيد التجنيد
Kailera Clinical SiteHolešovZlínقيد التجنيد
Kailera Clinical SiteNáchodHradec Králové Regionقيد التجنيد
Kailera Clinical SiteOlomoucقيد التجنيد
Kailera Clinical SitePardubiceقيد التجنيد
Kailera Clinical SitePragueقيد التجنيد
Kailera Clinical SitePraguePragueقيد التجنيد
Kailera Clinical SiteTrutnovHradec Králové Regionقيد التجنيد
Kailera Clinical SiteUherské Hradištěقيد التجنيد

يُدرَج 117 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 3 سبتمبر 2026

    أُضيف موقع

    4 sites added (167 total)

    163167

  2. 1 سبتمبر 2026

    أُضيف موقع

    47 sites added (163 total)

    116163

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

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