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Safety Study of LLF580 in Obese Volunteers

Primary Purpose

Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LLF580
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, hypertriglyceridemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LLF580

Placebo

Arm Description

LLF580 every 28 days * 3

Placebo to LLF580 every 28 days * 3

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability following repeated dosing of LLF580
To assess the safety and tolerability in obese subjects following repeated dosing of LLF580 by subcutaneous (SC) injection over 12 weeks.

Secondary Outcome Measures

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

Full Information

First Posted
February 9, 2018
Last Updated
October 7, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03466203
Brief Title
Safety Study of LLF580 in Obese Volunteers
Official Title
A 12 Week Phase Ib Randomized Investigator and Subject Blinded Placebo Controlled Repeat-dose Study of LLF580
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LLF580
Arm Type
Experimental
Arm Description
LLF580 every 28 days * 3
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to LLF580 every 28 days * 3
Intervention Type
Biological
Intervention Name(s)
LLF580
Intervention Description
LLF580 300mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to LLF580
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability following repeated dosing of LLF580
Description
To assess the safety and tolerability in obese subjects following repeated dosing of LLF580 by subcutaneous (SC) injection over 12 weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
LDL-C, HDL-C
Description
To assess the effects of LLF580 on lipid profiles.
Time Frame
12 weeks
Title
serum CTX-1, P1NP, and osteocalcin
Description
To assess the potential effects of LLF580 on these biomarkers.
Time Frame
12 weeks
Title
Body weight
Description
To assess the effects of LLF580 on weight.
Time Frame
12 weeks
Title
BMI
Description
To assess the effects of LLF580 on BMI
Time Frame
12 weeks
Title
serum BSAP
Description
To assess the potential effects of LLF580 on these biomarkers.
Time Frame
12 weeks
Title
urine NTX-1
Description
To assess the potential effects of LLF580 on these biomarkers.
Time Frame
12 weeks
Title
Total cholesterol
Description
To asses the effects of LLF580 on lipid profiles
Time Frame
12 weeks
Title
Triglycerides (fasting)
Description
To assess the effects of LLF580 on lipid profiles
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Novartis Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Novartis Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States
Facility Name
Novartis Investigative Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27265
Country
United States
Facility Name
Novartis Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Novartis Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
34431493
Citation
Rader DJ, Maratos-Flier E, Nguyen A, Hom D, Ferriere M, Li Y, Kompa J, Martic M, Hinder M, Basson CT, Yowe D, Diener J, Goldfine AB; CLLF580X2102 Study Team. LLF580, an FGF21 Analog, Reduces Triglycerides and Hepatic Fat in Obese Adults With Modest Hypertriglyceridemia. J Clin Endocrinol Metab. 2022 Jan 1;107(1):e57-e70. doi: 10.1210/clinem/dgab624.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17731
Description
Results for CLLF580X2102 can be found on the Novartis Clinical Trial Results Website
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=649
Description
A Plain Language Trial Summary is available on novartisclinicaltrials.com

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Safety Study of LLF580 in Obese Volunteers

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