The purpose of the study is to evaluate the safety and tolerability of multiple doses of LLF580 administered subcutaneously over 3 months in obese subjects. In addition, the study will also determine early efficacy signals in various metabolic diseases associated with elevated triglycerides and/or obesity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
61
Novartis Investigative Site
Jacksonville, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Overland Park, Kansas, United States
Novartis Investigative Site
Lincoln, Nebraska, United States
Number of Participants with Adverse Events as a Measure of Safety and Tolerability following repeated dosing of LLF580
To assess the safety and tolerability in obese subjects following repeated dosing of LLF580 by subcutaneous (SC) injection over 12 weeks.
Time frame: 12 weeks
LDL-C, HDL-C
To assess the effects of LLF580 on lipid profiles.
Time frame: 12 weeks
serum CTX-1, P1NP, and osteocalcin
To assess the potential effects of LLF580 on these biomarkers.
Time frame: 12 weeks
Body weight
To assess the effects of LLF580 on weight.
Time frame: 12 weeks
BMI
To assess the effects of LLF580 on BMI
Time frame: 12 weeks
serum BSAP
To assess the potential effects of LLF580 on these biomarkers.
Time frame: 12 weeks
urine NTX-1
To assess the potential effects of LLF580 on these biomarkers.
Time frame: 12 weeks
Total cholesterol
To asses the effects of LLF580 on lipid profiles
Time frame: 12 weeks
Triglycerides (fasting)
To assess the effects of LLF580 on lipid profiles
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Novartis Investigative Site
High Point, North Carolina, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Time frame: 12 weeks