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ALN-2232

Phase 1

Obesity | Small molecule | Metabolic |Alnylam Pharmaceuticals, Inc.|Last Updated: May 14, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment156
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07463846A Study to Evaluate ALN-2232 in Participants With ObesityPHASE1 RECRUITING 156Mar 2, 2026Mar 2, 2028May 14, 20261 Canada
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Study Endpoints
Primary Endpoints
Part A: Frequency of Adverse Events (AEs)
Up to 12 months
Part B: Percent Change from Baseline in Body Weight
Baseline up to Month 6
Part C: Percent Change from Baseline in Body Weight
Baseline up to Month 6
Secondary Endpoints
Part A: Change from Baseline in Proteins in Adipose Tissue
Baseline up to Month 12
Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-2232 in Plasma
Predose and up to 15 days postdose
Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-2232 in Plasma
Predose and up to 15 days postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: ALN-2232EXPERIMENTALParticipants will be administered a single dose of ALN-2232
Part A: PlaceboPLACEBO_COMPARATORParticipants will be administered a single dose of placebo
Part B: ALN-2232EXPERIMENTALParticipants will be administered multiple doses of ALN-2232
Part B: PlaceboPLACEBO_COMPARATORParticipants will be administered multiple doses of placebo
Part C: ALN-2232EXPERIMENTALParticipants will be administered multiple doses of ALN-2232
Part C: PlaceboPLACEBO_COMPARATORParticipants will be administered multiple doses of placebo
Part C: TirzepatideOTHERParticipants will be administered multiple doses of tirzepatide once weekly
Interventions
NameTypeDescription
ALN-2232DRUGALN-2232 will be administered subcutaneously (SC)
PlaceboDRUGPlacebo will be administered SC
TirzepatideDRUGTirzepatide will be administered SC
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: All Parts: * Has a body mass index (BMI) of ≥30 kg/m\^2 and \<40 kg/m\^2 * Has a hemoglobin A1c (HbA1c) \<6.5% Exclusion Criteria: All Parts: * Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise partici...

Countries:Canada
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07463846primaryCompletionDate: changed
LOWMay 24, 2026NCT07463846studyFirstPostDate: changed