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Completed

NCT Number: NCT03466203

Safety Study of LLF580 in Obese Volunteers

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.

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Key information

Conditions

Obesity Body Weight Dyslipidemias Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LLF580

Biological

LLF580 300mg

Placebo

Drug

Placebo to LLF580

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability following repeated dosing of LLF580

    Time frame: 12 weeks

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

Secondary outcomes

  1. LDL-C, HDL-C

    Time frame: 12 weeks

    To assess the effects of LLF580 on lipid profiles.

  2. serum CTX-1, P1NP, and osteocalcin

    Time frame: 12 weeks

    To assess the potential effects of LLF580 on these biomarkers.

  3. Body weight

    Time frame: 12 weeks

    To assess the effects of LLF580 on weight.

  4. BMI

    Time frame: 12 weeks

    To assess the effects of LLF580 on BMI

  5. serum BSAP

    Time frame: 12 weeks

    To assess the potential effects of LLF580 on these biomarkers.

  6. urine NTX-1

    Time frame: 12 weeks

    To assess the potential effects of LLF580 on these biomarkers.

  7. Total cholesterol

    Time frame: 12 weeks

    To asses the effects of LLF580 on lipid profiles

  8. Triglycerides (fasting)

    Time frame: 12 weeks

    To assess the effects of LLF580 on lipid profiles

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 12 Week Phase Ib Randomized Investigator and Subject Blinded Placebo Controlled Repeat-dose Study of LLF580

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 15, 2018
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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