Safety Study of LLF580 in Obese Volunteers

Novartis

Status and phase

Completed

Phase 1

Conditions

Obesity

Treatments

Biological: LLF580

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03466203

CLLF580X2102

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

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.