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Safety Study of LLF580 in Obese Volunteers

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ClinicalTrials.gov Identifier: NCT03466203
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Obesity Biological: LLF580 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 12 Week Phase Ib Randomized Investigator and Subject Blinded Placebo Controlled Repeat-dose Study of LLF580
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : March 4, 2019
Estimated Study Completion Date : June 24, 2019

Arm Intervention/treatment
Experimental: LLF580
LLF580 every 28 days * 3
Biological: LLF580
LLF580 300mg

Placebo Comparator: Placebo
Placebo to LLF580 every 28 days * 3
Drug: Placebo
Placebo to LLF580




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466203


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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United States, Florida
Novartis Investigative Site Recruiting
Jacksonville, Florida, United States, 32216
Novartis Investigative Site Recruiting
Miami, Florida, United States, 33126
United States, Kansas
Novartis Investigative Site Recruiting
Overland Park, Kansas, United States, 66212
United States, Nebraska
Novartis Investigative Site Recruiting
Lincoln, Nebraska, United States, 68502
United States, North Carolina
Novartis Investigative Site Recruiting
High Point, North Carolina, United States, 27265
United States, Pennsylvania
Novartis Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Novartis Investigative Site Recruiting
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03466203     History of Changes
Other Study ID Numbers: CLLF580X2102
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
obesity
hypertriglyceridemia