Safety Study of LLF580 in Obese Volunteers

Phase 1

Completed

• Conditions: Obesity
• Interventions: Biological: LLF580; Drug: Placebo

• Registration Number: NCT03466203
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-09
• Study Start: 2018-02-26
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-15
• Primary Completion: 2019-11-13
• Study Completion: 2019-11-13
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 understand and comply with the requirements of the study.

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Exclusion Criteria

• History of hepatobilliary disease.
• Liver disease or liver injury as indicated by abnormal liver function tests.
• Chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).
• Fasting triglycerides greater than or equal to 500 mg/dL [5.65 mmol/L], or concomitant use of drug treatment for hypertriglyceridemia (fibrates, omega-3 fatty acids, nicotinic acid).
• History of pancreatic injury or pancreatitis.
• History of hypersensitivity to drugs of similar biological class, FGF21 protein analogue, or Fc fusion proteins.
• History of bone disorders or low vitamin D level.
• Contraindications to MRI.
• Change in body weight (more than 5% self-reported OR 5 kg self-reported change during the previous 3 months).
• Use of weight loss drugs.
• Enrollment in a diet, weight loss or exercise programs.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LLF580	LLF580	LLF580 every 28 days \* 3
Placebo	Placebo	Placebo to LLF580 every 28 days \* 3

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
serum CTX-1, P1NP, and osteocalcin	12 weeks	To assess the potential effects of LLF580 on these biomarkers.
serum BSAP	12 weeks	To assess the potential effects of LLF580 on these biomarkers.
Triglycerides (fasting)	12 weeks	To assess the effects of LLF580 on lipid profiles
LDL-C, HDL-C	12 weeks	To assess the effects of LLF580 on lipid profiles.
Body weight	12 weeks	To assess the effects of LLF580 on weight.
BMI	12 weeks	To assess the effects of LLF580 on BMI
Total cholesterol	12 weeks	To asses the effects of LLF580 on lipid profiles
urine NTX-1	12 weeks	To assess the potential effects of LLF580 on these biomarkers.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Knoxville, Tennessee, United States