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Ribupatide (KAI-9531)

Phase 3

Obesity | Small molecule | Metabolic |Kailera Therapeutics, Inc.|Last Updated: Sep 3, 2026

Target and mechanism

Molecular targetGLP-1/GIP
Target class-Tide (Peptide)
ModalitySmall molecule

Also known as KAI-9531, Ribupatide

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment3,790

FDA Designations

No designations recorded

Clinical trial landscape

Ribupatide (KAI-9531) · 6 trials · 7 indications

Phase 3 3Phase 2 1Phase 1 2
NCT07284901Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and DiabetesObesity With Diabetes
RECRUITING1,156 Analytics
NCT07284979Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have DiabetesObesity
RECRUITING1,200 Analytics
NCT07284875Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have DiabetesObesity
RECRUITING2,340 Analytics
PHASE3RECRUITING
Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
Obesity With DiabetesUnlock trial analytics
PHASE3RECRUITING
Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
ObesityUnlock trial analytics
PHASE3RECRUITING
Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Baseline, Week 76
Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Baseline, Week 76
Percent Change From Baseline in Body Weight at Week 76
Baseline, Week 76
Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Baseline, Week 76
Percent Change From Baseline in Body Weight at Week 48
Baseline, Week 48
Maximum Observed Concentration (Cmax) of KAI-9531
Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose
Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-9531
Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-9531
Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Ribupatide
Predose up to 816 hours postdose on Day 35
Area Under Concentration Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-t) of Ribupatide
Predose up to 816 hours postdose on Day 35
Area Under Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Ribupatide
Predose up to 816 hours postdose on Day 35

Secondary Endpoints

Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Baseline, Week 76
Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Baseline, Week 76
Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Baseline, Week 76
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ribupatide: Dose 1EXPERIMENTALParticipants will receive Dose 1 of ribupatide once weekly.
Ribupatide: Dose 2EXPERIMENTALParticipants will receive Dose 2 of ribupatide once weekly.
Ribupatide: Dose 3EXPERIMENTALParticipants will receive Dose 3 of ribupatide once weekly.
Ribupatide: Dose 4EXPERIMENTALParticipants will receive Dose 4 of ribupatide once weekly.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to ribupatide once weekly.
SemaglutideACTIVE_COMPARATORParticipants will receive semaglutide once weekly.
KAI-9531: Dose 1EXPERIMENTALParticipants will receive Dose 1 of KAI-9531 once weekly.
KAI-9531: Dose 2EXPERIMENTALParticipants will receive Dose 2 of KAI-9531 once weekly.
KAI-9531: Dose 3EXPERIMENTALParticipants will receive Dose 3 of KAI-9531 once weekly.
KAI-9531: Dose 4EXPERIMENTALParticipants will receive Dose 4 of KAI-9531 once weekly.
KAI-9531: Abdomen Injection SiteEXPERIMENTALParticipants will receive KAI-9531 as a SC injection into the abdomen on Day 1 of either Treatment Period 1, 2 or 3.
KAI-9531: Thigh Injection SiteEXPERIMENTALParticipants will receive KAI-9531 as a SC injection into the thigh on Day 1 of either Treatment Period 1, 2 or 3.
KAI-9531: Upper Arm Injection SiteEXPERIMENTALParticipants will receive KAI-9531 as a SC injection into the upper arm on Day 1 of either Treatment Period 1, 2 or 3.
RibupatideEXPERIMENTALParticipants will receive ribupatide once weekly.

Interventions

NameTypeDescription
RibupatideDRUGSC Injection
PlaceboDRUGSC Injection
SemaglutideDRUGSC Injection
KAI-9531DRUGSC Injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites167

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 treatm...

Countries:United StatesArgentinaAustraliaBulgariaCzechiaGermanyNew ZealandPolandPuerto RicoSpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 3, 2026NCT07284875lastUpdatePostDate: changed
LOWSep 3, 2026NCT07284901lastUpdatePostDate: changed
LOWSep 3, 2026NCT07793929lastUpdatePostDate: changed
LOWSep 3, 2026NCT07284875lastUpdatePostDate: changed
LOWSep 3, 2026NCT07284901lastUpdatePostDate: changed
LOWSep 3, 2026NCT07793929lastUpdatePostDate: changed
LOWSep 1, 2026NCT07284979lastUpdatePostDate: changed
LOWSep 1, 2026NCT07284901lastUpdatePostDate: changed
LOWSep 1, 2026NCT07284875lastUpdatePostDate: changed
LOWSep 1, 2026NCT07284979lastUpdatePostDate: changed
LOWSep 1, 2026NCT07284901lastUpdatePostDate: changed
LOWSep 1, 2026NCT07284875lastUpdatePostDate: changed
LOWAug 31, 2026NCT07793929NEW_TRIAL: changed
LOWAug 31, 2026NCT07793929NEW_TRIAL: changed
MEDIUMJul 22, 2026NCT07284979primaryCompletionDate: changed
MEDIUMJul 22, 2026NCT07284875Enrollment: 1800 → 2340
MEDIUMJul 22, 2026NCT07284979primaryCompletionDate: changed
MEDIUMJul 22, 2026NCT07284875Enrollment: 1800 → 2340
HIGHJul 15, 2026NCT07284901Enrollment: 1700 → 1156
HIGHJul 15, 2026NCT07284901Enrollment: 1700 → 1156

Frequently asked questions about Ribupatide (KAI-9531)

What is Ribupatide (KAI-9531)?

Ribupatide is an investigational small molecule peptide developed by Kailera Therapeutics for metabolic conditions, including obesity, obesity with diabetes, and related renal impairment studies. It is also known as KAI-9531. It is given once weekly in clinical trials and is not yet approved for any indication.

What does Ribupatide target?

Ribupatide targets the GLP-1 and GIP receptors, a dual incretin receptor mechanism. It belongs to the peptide class of molecules, reflected in the -tide naming. This dual GLP-1/GIP targeting is the basis for its investigation in obesity and obesity with diabetes.

Who makes Ribupatide?

Ribupatide is developed by Kailera Therapeutics, Inc., which trades under the ticker KLRA. The company is running the clinical program for the asset across obesity, obesity with diabetes, and renal impairment settings.

What phase is Ribupatide in?

Ribupatide is in clinical development spanning Phase 1 through Phase 3. A Phase 1 renal impairment pharmacokinetic study is not yet recruiting, while two Phase 3 trials and one Phase 2 trial in obesity are currently recruiting. It is investigational and not approved.

What clinical trials is Ribupatide in?

Ribupatide trials include NCT07793929, a Phase 1 renal impairment pharmacokinetic study; NCT07458269, a Phase 2 obesity trial; NCT07284979, a Phase 3 obesity trial comparing it with semaglutide and placebo; and NCT07284901, a Phase 3 trial in obesity or overweight with diabetes.

Is Ribupatide the same as KAI-9531?

Yes, Ribupatide and KAI-9531 refer to the same investigational compound from Kailera Therapeutics. KAI-9531 is the alternate code name used in some trial titles, such as the Phase 2 obesity study, while Ribupatide is the name used in the Phase 3 program.