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LLF580

Phase 1

Obesity | Monoclonal antibody | Metabolic |Novartis AG|Last Updated: Oct 12, 2021

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_CONTROLLED
Total Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03466203Safety Study of LLF580 in Obese VolunteersPHASE1 COMPLETED 61Feb 26, 2018Nov 13, 2019Oct 12, 20217 United States
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events as a Measure of Safety and Tolerability following repeated dosing of LLF580
12 weeks

To assess the safety and tolerability in obese subjects following repeated dosing of LLF580 by subcutaneous (SC) injection over 12 weeks.

Secondary Endpoints
LDL-C, HDL-C
12 weeks
serum CTX-1, P1NP, and osteocalcin
12 weeks
Body weight
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LLF580EXPERIMENTALLLF580 every 28 days \* 3
PlaceboPLACEBO_COMPARATORPlacebo to LLF580 every 28 days \* 3
Interventions
NameTypeDescription
LLF580BIOLOGICALLLF580 300mg
PlaceboDRUGPlacebo to LLF580
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Body mass index (BMI) within the range of 30 to 45 kg/m2, inclusive, with ethnic adjustment (≥27.5 kg/m2 for Asian individuals). * Fasting triglyceride 150 - 500 mg/dL (1.69 - 5.65 mmol/L), inclusive, at screening. * Able to communicate well with the investigator, to understan...

Countries:United States
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