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Ribupatide (KAI-9531)

Phase 3

Obesity | Peptides | Metabolic |Kailera Therapeutics, Inc.|Trials Updated: Oct 6, 2026

Ribupatide (KAI-9531) target and mechanism

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

Also known as Ribupatide, KAI-9531

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials5
Total Enrollment5,366

FDA Designations

No designations recorded

Ribupatide (KAI-9531) clinical trials

Ribupatide (KAI-9531) · 5 trials · 6 indications

Phase 3 3Phase 2 1Phase 1 1
NCT07284901Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and DiabetesObesity With Diabetes
ACTIVE NOT_RECRUITING1,270 Analytics
NCT07284979Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have DiabetesObesity
ACTIVE NOT_RECRUITING1,270 Analytics
NCT07284875Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have DiabetesObesity
ACTIVE NOT_RECRUITING2,530 Analytics
PHASE3ACTIVE NOT_RECRUITING
Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
Obesity With DiabetesUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
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
PHASE3ACTIVE NOT_RECRUITING
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 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.
RibupatideEXPERIMENTALParticipants will receive ribupatide once weekly.

Interventions

NameTypeDescription
RibupatideDRUGSC Injection
PlaceboDRUGSC Injection
SemaglutideDRUGSC Injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites173

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)

MEDIUMOct 30, 2026NCT07458269Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMOct 30, 2026NCT07458269Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMOct 30, 2026NCT07458269Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMOct 6, 2026NCT07284979Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMOct 6, 2026NCT07284875Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMOct 6, 2026NCT07284901Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMOct 6, 2026NCT07284979Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMOct 6, 2026NCT07284875Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMOct 6, 2026NCT07284901Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWOct 1, 2026NCT07793929Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 1, 2026NCT07793929Status: NOT_YET_RECRUITING → RECRUITING
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

Frequently asked questions about Ribupatide (KAI-9531)

What is ribupatide (KAI-9531)?

Ribupatide, also known as KAI-9531, is an investigational small molecule developed by Kailera Therapeutics for metabolic conditions. It is being studied in obesity, obesity with diabetes, and end stage renal disease. It is a peptide-class agent that targets the GLP-1 and GIP receptors and is given once weekly in the obesity trials.

What does ribupatide target?

Ribupatide targets the GLP-1 and GIP receptors. It is a peptide-class molecule that engages both incretin receptors, and the obesity studies administer it once weekly. Targeting both GLP-1 and GIP places it among dual incretin receptor agonists being developed for metabolic disease.

Who is developing ribupatide?

Ribupatide is being developed by Kailera Therapeutics, Inc., which trades under the ticker KLRA. The company is running the clinical program for the drug across obesity, obesity with diabetes, and renal impairment settings, with trials conducted in the United States and several additional countries.

What phase is ribupatide in?

Ribupatide is in clinical development across multiple phases. A Phase 1 pharmacokinetic study in renal impairment is recruiting, while two Phase 3 obesity trials and one Phase 2 obesity trial are active but not recruiting. Ribupatide is investigational and has not been approved by the FDA.

What clinical trials is ribupatide in?

Ribupatide is being studied in NCT07793929, a Phase 1 pharmacokinetic trial in renal impairment with 32 participants, and NCT07458269, a Phase 2 obesity trial with 264 participants. Two Phase 3 obesity trials are also underway: NCT07284979 comparing ribupatide with semaglutide and placebo, and NCT07284901 in obesity or overweight with diabetes, each enrolling 1,270 participants.

Is ribupatide the same as KAI-9531?

Yes, ribupatide and KAI-9531 refer to the same investigational drug from Kailera Therapeutics. Ribupatide is the name used in trial titles, and KAI-9531 appears alongside it in the company's study listings, so searches for either name lead to the same clinical program in obesity and related metabolic conditions.