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LLF580

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

LLF580 · 1 trial · 1 indication

Phase 1 1
NCT03466203Safety Study of LLF580 in Obese VolunteersObesity
COMPLETED61 Analytics
PHASE1COMPLETED
Safety Study of LLF580 in Obese Volunteers
ObesityUnlock trial analytics

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 to 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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Frequently asked questions about LLF580

What is LLF580 used for?

LLF580 is an investigational monoclonal antibody being developed for the treatment of obesity. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being studied in obese volunteers to evaluate its safety and tolerability.

What does LLF580 target?

LLF580 is a monoclonal antibody, a type of biologic drug designed to bind to a specific target in the body. However, the specific molecular target of LLF580 has not been disclosed in available information. The drug is being studied for its potential effects in obesity, but its exact mechanism of action remains undisclosed.

Who makes LLF580?

LLF580 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research on this drug for the treatment of obesity.

What phase is LLF580 in?

LLF580 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing to assess its safety and tolerability in humans.

What clinical trials is LLF580 in?

LLF580 has one completed Phase 1 clinical trial registered as NCT03466203, titled "Safety Study of LLF580 in Obese Volunteers." This randomized, double-blind, placebo-controlled study enrolled 61 participants in the United States and evaluated the drug's safety in obese individuals aged 18 years and older.