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Setmelanotide

Phase 3

Obesity | Small molecule | Rare Disease |Rhythm Pharmaceuticals, Inc.|Last Updated: Feb 10, 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 Trials1
Total Enrollment296
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05093634EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R PathwayPHASE3 ACTIVE NOT_RECRUITING 296 — — Dec 10, 2021Dec 31, 2026Feb 10, 202656 United States, Canada +8
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Study Endpoints
Primary Endpoints
Difference in mean change in body weight in patients treated with setmelanotide compared to placebo, assessed as percent change in BMI
Baseline to 52 weeks
Secondary Endpoints
The proportion of patients who achieve at least 5% reduction in BMI in patients treated with setmelanotide compared to placebo
Baseline to 52 weeks
The difference in mean change in body weight in adult patients treated with setmelanotide compared to placebo, assessed as percent change in baseline body weight
Baseline to 52 weeks
The difference in mean percent change in the weekly average most hunger score in patients treated with setmelanotide compared to placebo
Baseline to 52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
POMC or PCSK1 variantEXPERIMENTAL1:1 Randomization
LEPR variantEXPERIMENTAL1:1 Randomization
NCOA1 (SRC1) variantEXPERIMENTAL1:1 Randomization
SH2B1 variantEXPERIMENTAL1:1 Randomization
Interventions
NameTypeDescription
SetmelanotideDRUGSubcutaneous Injection
PlaceboDRUGSubcutaneous Injection
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Eligibility Criteria
Age Range6 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites56

Inclusion Criteria: * Patients must have a pre-identified: * Heterozygous genetic variant in the POMC gene or PCSK1 gene * Heterozygous genetic variant in the LEPR gene * Homozygous, heterozygous, or compound heterozygous variant in the NCOA1 (SRC1) * Homozygous, heterozygous, or compound ...

Countries:United StatesCanadaFranceGermanyGreeceIsraelNetherlandsPuerto RicoSpainUnited Kingdom
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Competitive Landscape -Obesity 202 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY43PHASE3Retatrutide, Orforglipron, Tirzepatide, Ixekizumab, Eloralintide
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
Regeneron Pharmaceuticals, Inc.REGN3PHASE3Mibavademab, Trevogrumab-Part A, Trevogrumab-Part B and Part C, Garetosmab, Semaglutide
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
Biohaven Ltd.BHVN1PHASE2Taldefgrobep Alfa
Skye Bioscience, Inc.SKYE1PHASE2Nimacimab, semaglutide
Palatin Technologies, IncPTN1PHASE2bremelanotide, tirzepatide
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)
LOWMay 26, 2026NCT05093634primaryCompletionDate: changed
LOWMay 24, 2026NCT05093634studyFirstPostDate: changed