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KAI-7535

Phase 2

Obesity | Small molecule | Metabolic |Kailera Therapeutics, Inc.|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment338
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07497880Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related ComorbidityPHASE2 RECRUITING 320 — — Apr 6, 2026Jul 7, 2027Jun 5, 202619 United States
NCT07294898A Study to Investigate the Effect of a Low-fat Meal and Evening Dosing on KAI-7535 in Participants Living With Obesity or OverweightPHASE1 COMPLETED 18 — — Dec 15, 2025Jan 26, 2026Jan 29, 20261 United States
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Study Endpoints
Primary Endpoints
Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
Baseline, Week 44
Time to Maximum Observed Concentration (Tmax) of KAI-7535
Pre-dose and up to 60 hours post-dose
Maximum Observed Concentration (Cmax) of KAI-7535
Pre-dose and up to 60 hours post-dose
Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-7535
Pre-dose and up to 60 hours post-dose
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-7535
Pre-dose and up to 60 hours post-dose
Secondary Endpoints
Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
Baseline, Week 44
Change from Baseline in Body Mass Index (BMI) at Week 44 for Participants Without Diabetes Mellitus
Baseline, Week 44
Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Without Diabetes Mellitus
Week 44
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
KAI-7535: Dose Schedule 1EXPERIMENTALParticipants will receive KAI-7535 once daily.
KAI-7535: Dose Schedule 2EXPERIMENTALParticipants will receive KAI-7535 once daily.
KAI-7535: Dose Schedule 3EXPERIMENTALParticipants will receive KAI-7535 once daily.
KAI-7535: Dose Schedule 4EXPERIMENTALParticipants will receive KAI-7535 once daily.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to KAI-7535 once daily.
KAI-7535: Morning Dosing, FedEXPERIMENTALParticipants will receive KAI-7535 in the morning following a meal on dosing days.
KAI-7535: Morning Dosing, FastedEXPERIMENTALParticipants will receive KAI-7535 in the morning following an overnight fast on dosing days.
KAI-7535: Evening DosingEXPERIMENTALParticipants will receive KAI-7535 in the evening on dosing days.
Interventions
NameTypeDescription
KAI-7535DRUGOral tablets
PlaceboDRUGOral tablets
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites19

Key Inclusion Criteria: * For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m\^2) or BMI ≥27 kg/m\^2 and a previous diagnosis of at least 1 of the following: * Hypertension * Dyslipidemia * Obstructive sleep apnea * Cardiovascular dise...

Countries:United States
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Competitive Landscape -Obesity 202 trials
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Amgen Inc.AMGN10PHASE3Maridebart cafraglutide, Maridebart Cafraglutide, Moxifloxacin, COC
Novo Nordisk A/S Sponsored ADR Class BNVO47PHASE3Cagrilintide, Semaglutide, Liraglutide, CagriSema, NNC0487-0111
Rhythm Pharmaceuticals, Inc.RYTM8PHASE3Setmelanotide, Bivamelagon, Part C: RM-718, Part D: RM-718
Pfizer Inc.PFE2PHASE3PF-08653944
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Vanda Pharmaceuticals Inc.VNDA1PHASE3Tradipitant
AstraZeneca PLCAZN3PHASE2AZD6234, AZD9550, Plocebo
Kailera Therapeutics, Inc.KLRA4PHASE3KAI-9531, Semaglutide, KAI-7535
Structure Therapeutics, Inc. Sponsored ADRGPCR3PHASE2Aleniglipron
PfizerMTSR3PHASE3MET097, MET233 and MET097
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Veru IncVERU1PHASE2Enobosarm, Semaglutide weekly
Arrowhead Pharmaceuticals, Inc.ARWR2PHASE1ARO-INHBE, Tirzepatide, ARO-ALK7
Alnylam Pharmaceuticals, IncALNY1PHASE1ALN-2232, Tirzepatide
Gilead Sciences, Inc.GILD1PHASE1GS-4571, Omeprazole
AbbVie, Inc.ABBV1PHASE1ABBV-295
MBX Biosciences, Inc.MBX1PHASE1MBX 4291
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT07497880lastUpdatePostDate: changed
LOWJun 5, 2026NCT07497880lastUpdatePostDate: changed
LOWJun 5, 2026NCT07497880lastUpdatePostDate: changed
LOWJun 5, 2026NCT07497880lastUpdatePostDate: changed
LOWMay 29, 2026NCT07497880lastUpdatePostDate: changed
LOWMay 29, 2026NCT07497880lastUpdatePostDate: changed
LOWMay 29, 2026NCT07497880lastUpdatePostDate: changed
LOWMay 26, 2026NCT07497880primaryCompletionDate: changed
LOWMay 24, 2026NCT07497880studyFirstPostDate: changed