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KAI-9531

Phase 3

Obesity | Small molecule | Metabolic |Kailera Therapeutics, Inc.|Last Updated: Jul 15, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment3,250
FDA Designations
No designations recorded
Clinical trial landscape

KAI-9531 · 5 trials · 5 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
RECRUITING1,156 Analytics
NCT07284979Efficacy and Safety of KAI-9531 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 KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have DiabetesObesity
RECRUITING1,800 Analytics
PHASE3RECRUITING
Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
Obesity With Diabetes
NCT072849011,156
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PHASE3RECRUITING
Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
Obesity
NCT072849791,200
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PHASE3RECRUITING
Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
Obesity
NCT072848751,800
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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
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.
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.
SemaglutideACTIVE_COMPARATORParticipants will receive semaglutide 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.
Interventions
NameTypeDescription
RibupatideDRUGSC Injection
PlaceboDRUGSC Injection
KAI-9531DRUGSC Injection
SemaglutideDRUGSC Injection
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites116

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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Competitive Landscape -Obesity 198 trials

Top 20 of 33 competitors

CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN9PHASE3Maridebart cafraglutide
Eli Lilly and CompanyLLY42PHASE3Retatrutide
Novo Nordisk A/S Sponsored ADR Class BNVO46PHASE3Cagrilintide, Semaglutide
Rhythm Pharmaceuticals, Inc.RYTM8PHASE3Setmelanotide
Regeneron Pharmaceuticals, Inc.REGN3PHASE3Mibavademab
Pfizer Inc.PFE2PHASE3PF-08653944
Vanda Pharmaceuticals Inc.VNDA1PHASE3Tradipitant
Kailera Therapeutics, Inc.KLRA4PHASE3KAI-9531
AstraZeneca PLCAZN3PHASE2AZD6234
Structure Therapeutics, Inc. Sponsored ADRGPCR3PHASE2Undisclosed
PfizerMTSR3PHASE3MET097
Biohaven Ltd.BHVN1PHASE2Taldefgrobep Alfa
Skye Bioscience, Inc.SKYE1PHASE2Nimacimab, semaglutide
Palatin Technologies, Inc.PTN1PHASE2bremelanotide, tirzepatide
Veru IncVERU1PHASE2Enobosarm, Semaglutide weekly
Arrowhead Pharmaceuticals, Inc.ARWR2PHASE1ARO-INHBE, Tirzepatide
Alnylam Pharmaceuticals, IncALNY1PHASE1ALN-2232, Tirzepatide
Gilead Sciences, Inc.GILD1PHASE1GS-4571, Omeprazole
MBX Biosciences, Inc.MBX1PHASE1MBX 4291
AbbVie, Inc.ABBV1PHASE1ABBV-295
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Recent Changes (Last 90 Days)
HIGHJul 15, 2026NCT07284901Enrollment: 1700 → 1156
HIGHJul 15, 2026NCT07284901Enrollment: 1700 → 1156
LOWJun 18, 2026NCT07284979lastUpdatePostDate: changed
LOWJun 18, 2026NCT07284875lastUpdatePostDate: changed
LOWJun 18, 2026NCT07284901lastUpdatePostDate: changed
LOWJun 18, 2026NCT07284979lastUpdatePostDate: changed
LOWJun 18, 2026NCT07284875lastUpdatePostDate: changed
LOWJun 18, 2026NCT07284901lastUpdatePostDate: changed
LOWJun 18, 2026NCT07284979lastUpdatePostDate: changed
LOWJun 18, 2026NCT07284875lastUpdatePostDate: changed
LOWJun 18, 2026NCT07284901lastUpdatePostDate: changed
LOWJun 8, 2026NCT07284979lastUpdatePostDate: changed
LOWJun 8, 2026NCT07284875lastUpdatePostDate: changed
LOWJun 8, 2026NCT07284901lastUpdatePostDate: changed
LOWJun 8, 2026NCT07284979lastUpdatePostDate: changed
LOWJun 8, 2026NCT07284875lastUpdatePostDate: changed
LOWJun 8, 2026NCT07284901lastUpdatePostDate: changed
LOWJun 8, 2026NCT07284979lastUpdatePostDate: changed
LOWJun 8, 2026NCT07284875lastUpdatePostDate: changed
LOWJun 8, 2026NCT07284901lastUpdatePostDate: changed