Safety Study of LLF580 in Obese Volunteers



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:12/5/2018
Start Date:February 26, 2018
End Date:June 24, 2019
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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

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.


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.
We found this trial at
7
sites
Knoxville, Tennessee 37934
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High Point, North Carolina 27262
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Jacksonville, Florida 32216
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Jacksonville, FL
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Lincoln, Nebraska 68506
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Lincoln, NE
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Miami, Florida 33136
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Miami, FL
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Overland Park, Kansas 66210
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Overland Park, KS
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Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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