ObesityPhase 1NCT03466203
Safety Study of LLF580 in Obese Volunteers
A Phase 1 study testing LLF580 in people with Obesity, run by Novartis Pharmaceuticals at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- LLF580
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Feb 2018to 13 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Novartis Investigative Site
High Point, North Carolina, 27265
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
Knoxville, Tennessee, 37920
Novartis Investigative Site
Lincoln, Nebraska, 68502
Novartis Investigative Site
Miami, Florida, 33126
Novartis Investigative Site
Overland Park, Kansas, 66212
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- LLF580, Placebo
- Keywords
- obesity, hypertriglyceridemia
- Medical subject headings
- Obesity, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLF580Biological
LLF580 300mg
PlaceboDrug
Placebo to LLF580
| Study group | Role | What they receive |
|---|---|---|
| LLF580 | Experimental | LLF580 every 28 days * 3 Receives: Biological: LLF580 |
| Placebo | Placebo comparator | Placebo to LLF580 every 28 days * 3 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (8)
LDL-C, HDL-C
To assess the effects of LLF580 on lipid profiles.
Measured: 12 weeks
serum CTX-1, P1NP, and osteocalcin
To assess the potential effects of LLF580 on these biomarkers.
Measured: 12 weeks
Body weight
To assess the effects of LLF580 on weight.
Measured: 12 weeks
BMI
To assess the effects of LLF580 on BMI
Measured: 12 weeks
serum BSAP
To assess the potential effects of LLF580 on these biomarkers.
Measured: 12 weeks
urine NTX-1
To assess the potential effects of LLF580 on these biomarkers.
Measured: 12 weeks
Total cholesterol
To asses the effects of LLF580 on lipid profiles
Measured: 12 weeks
Triglycerides (fasting)
To assess the effects of LLF580 on lipid profiles
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start26 Feb 2018
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466203
- Sponsor's protocol ID
- CLLF580X2102
- Status last verified
- Oct 2021
- First submitted
- 9 Feb 2018
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 34431493
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Week Phase Ib Randomized Investigator and Subject Blinded Placebo Controlled Repeat-dose Study of LLF580
- ClinicalTrials.gov ID
- NCT03466203
- Acronym / sponsor ID
- CLLF580X2102
- Conditions
- Obesity
- Keywords
- obesity, hypertriglyceridemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLF580 | Experimental | Biological: LLF580LLF580 every 28 days * 3 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to LLF580 every 28 days * 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLF580LLF580 300mg | Biological | LLF580 |
| PlaceboPlacebo to LLF580 | Drug | Placebo |
Primary outcome
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.
8 secondary outcomes
LDL-C, HDL-C
Time frame: 12 weeks
serum CTX-1, P1NP, and osteocalcin
Time frame: 12 weeks
Body weight
Time frame: 12 weeks
BMI
Time frame: 12 weeks
serum BSAP
Time frame: 12 weeks
urine NTX-1
Time frame: 12 weeks
Total cholesterol
Time frame: 12 weeks
Triglycerides (fasting)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 34431493Rader 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 for CLLF580X2102 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LLF580 in people with Obesity, run by Novartis Pharmaceuticals at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability following repeated dosing of LLF580 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03466203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.