Nonalcoholic Steatohepatitis (NASH)Phase 2NCT02443116

Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

A Phase 2 study testing NGM282 in people with Nonalcoholic Steatohepatitis (NASH), run by NGM Biopharmaceuticals, Inc at 22 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Nonalcoholic Steatohepatitis (NASH)
What is being tested?: NGM282
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 254 participants
Where: 22 sitesin 3 countries
Study dates: 31 Jul 2015to 17 Jan 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females, between 18 and 75 years of age, inclusive
Histologically confirmed NASH diagnosis

Who cannot join

Clinically significant acute or chronic liver disease
Prior liver transplantation

Trial locations and contacts

22 sites in 3 countries.

Country

City, postcode or hospital

22 sites in 3 countries

United States17 sites

NGM Clinical Study Site 922
Chandler, Arizona, 85224
NGM Clinical Study Site 904
Charlottesville, Virginia, 22908
NGM Clinical Study Site 906
Chicago, Illinois, 60611
NGM Clinical Study Site 910
Dallas, Texas, 75246
NGM Clinical Study Site 902
Denver, Colorado
NGM Clinical Study Site 903
Durham, North Carolina, 27710
NGM Clinical Study Site 921
Germantown, Tennessee, 38138
NGM Clinical Study Site 918
Kansas City, Missouri, 64131
NGM Clinical Study Site 917
Lakewood Rch, Florida, 34211
NGM Clinical Study Site 924
Los Angeles, California, 90057
NGM Clinical Study Site 911
Richmond, Virginia, 23226
NGM Clinical Study Site 920
Rollingwood, Texas, 78746
NGM Clinical Study Site 909
San Antonio, Texas, 78229
NGM Clinical Study Site 905
San Antonio, Texas, 78234
NGM Clinical Study Site 901
San Diego, California, 92103
NGM Clinical Study Site 908
Seattle, Washington, 98122
NGM Clinical Study Site 923
Tucson, Arizona, 85712

Other trials in United States

Australia4 sites

NGM Clinical Study Site 704
Adelaide, South Australia, 5042
NGM Clinical Study Site 701
Melbourne, Victoria, 3004
NGM Clinical Study Site 705
Melbourne, Victoria, 3065
NGM Clinical Study Site 703
Sydney, New South Wales, 2050

Other trials in Australia

Puerto Rico1 site

NGM Clinical Study Site 916
San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study With Additional Open-label, Single-blind and Placebo-controlled Cohorts to Assess the Safety, Tolerability, and Efficacy of NGM282 in Patients With Nonalcoholic Steatohepatitis

The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.

Conditions: Nonalcoholic Steatohepatitis (NASH)
Being tested: NGM282, Placebo
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NGM282Biological
PlaceboOther

Study groups in NCT02443116
Study group	Role	What they receive
Cohort 1 - Placebo	Placebo comparator	Cohort 1 - Placebo Receives: Other: Placebo
Cohort 1 - NGM282 3mg	Experimental	Cohort 1 - NGM282 3mg Receives: Biological: NGM282
Cohort 1 - NGM282 6mg	Experimental	Cohort 1 - NGM282 6mg Receives: Biological: NGM282
Cohort 2 - NGM282 0.3mg	Experimental	Cohort 2 - NGM282 0.3mg Receives: Biological: NGM282
Cohort 2 - NGM282 1mg	Placebo comparator	Cohort 2 - NGM282 1mg Receives: Biological: NGM282
Cohort 2 - NGM282 3mg	Experimental	Cohort 2 - NGM282 3mg Receives: Biological: NGM282
Cohort 3 - NGM282 1mg	Experimental	Cohort 3 - NGM282 1mg Receives: Biological: NGM282
Cohort 4 - Placebo	Placebo comparator	Cohort 4 - Placebo Receives: Other: Placebo
Cohort 4 - NGM282 1mg	Experimental	Cohort 4 - NGM282 1mg Receives: Biological: NGM282

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Absolute Liver Fat Content (Part 1)
Absolute liver fat content was assessed using magnetic resonance imaging (MRI).
Measured: Up to Week 12
Change in Absolute Liver Fat Content (Part 2)
Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Measured: Up to Week 12
Change in Absolute Liver Fat Content (Part 3)
Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Measured: Up to Week 24

Secondary outcomes (5)

Percentage Change in Liver Fat Content (Part 1)
Percentage change in liver fat content was assessed using magnetic resonance imaging (MRI).
Measured: Up to Week 12
Change in Absolute Liver Fat Content (Part 2)
Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Measured: Up to Week 18
Percentage Change in Liver Fat Content (Part 2)
Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Measured: Up to Week 18
Change in Absolute Liver Fat Content (Part 3)
Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Measured: Up to Week 30
Percentage Change in Liver Fat Content (Part 3)
Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Measured: Up to Week 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 201517 Jan 2020

First posted13 May 2015 (estimated)
Study start31 Jul 2015
Primary completion6 Dec 2019
Study completion17 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Nonalcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 254 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02443116
Sponsor's protocol ID: 15-0105
Status last verified: Jul 2025
First submitted: 11 May 2015
Last updated: 23 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Alkhouri N, Beyer C, Shumbayawonda E, Andersson A, Yale K, Rolph T, Chung RT, Vuppalanchi R, Cusi K, Loomba R, Pansini M, Dennis A. Decreases in cT1 and liver fat content reflect treatment-induced histological improvements in MASH. J Hepatol. 2025 Mar;82(3):438-445. doi: 10.1016/j.jhep.2024.08.031. Epub 2024 Sep 25.
PubMed 39326675
Nedrud MA, Chaudhry M, Middleton MS, Moylan CA, Lerebours R, Luo S, Farjat A, Guy C, Loomba R, Abdelmalek MF, Sirlin CB, Bashir MR. MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. Radiology. 2023 Mar;306(3):e220743. doi: 10.1148/radiol.220743. Epub 2022 Nov 1.
PubMed 36318027
Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun.
PubMed 33898959
Loomba R, Ling L, Dinh DM, DePaoli AM, Lieu HD, Harrison SA, Sanyal AJ. The Commensal Microbe Veillonella as a Marker for Response to an FGF19 Analog in NASH. Hepatology. 2021 Jan;73(1):126-143. doi: 10.1002/hep.31523. Epub 2020 Dec 11.
PubMed 32794259
Harrison SA, Neff G, Guy CD, Bashir MR, Paredes AH, Frias JP, Younes Z, Trotter JF, Gunn NT, Moussa SE, Kohli A, Nelson K, Gottwald M, Chang WCG, Yan AZ, DePaoli AM, Ling L, Lieu HD. Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Jan;160(1):219-231.e1. doi: 10.1053/j.gastro.2020.08.004. Epub 2020 Aug 8.
PubMed 32781086
Harrison SA, Rinella ME, Abdelmalek MF, Trotter JF, Paredes AH, Arnold HL, Kugelmas M, Bashir MR, Jaros MJ, Ling L, Rossi SJ, DePaoli AM, Loomba R. NGM282 for treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2018 Mar 24;391(10126):1174-1185. doi: 10.1016/S0140-6736(18)30474-4. Epub 2018 Mar 5.
PubMed 29519502

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
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All Nonalcoholic Steatohepatitis (NASH) trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study With Additional Open-label, Single-blind and Placebo-controlled Cohorts to Assess the Safety, Tolerability, and Efficacy of NGM282 in Patients With Nonalcoholic Steatohepatitis
ClinicalTrials.gov ID: NCT02443116
Acronym / sponsor ID: 15-0105
Conditions: Nonalcoholic Steatohepatitis (NASH)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 254 participants (actual)
Lead sponsor: NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
Collaborators: NGM Biopharmaceuticals Australia Pty Ltd
Study start: 31 Jul 2015 (actual)
Primary completion: 6 Dec 2019 (actual)
Study completion: 17 Jan 2020 (actual)
First posted: 13 May 2015 (estimated)
Results: Posted 26 Jun 2025

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 this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 9

Arm	Type	Receives
Cohort 1 - Placebo	Placebo comparator	Other: PlaceboCohort 1 - Placebo
Cohort 1 - NGM282 3mg	Experimental	Biological: NGM282Cohort 1 - NGM282 3mg
Cohort 1 - NGM282 6mg	Experimental	Biological: NGM282Cohort 1 - NGM282 6mg
Cohort 2 - NGM282 0.3mg	Experimental	Biological: NGM282Cohort 2 - NGM282 0.3mg
Cohort 2 - NGM282 1mg	Placebo comparator	Biological: NGM282Cohort 2 - NGM282 1mg
Cohort 2 - NGM282 3mg	Experimental	Biological: NGM282Cohort 2 - NGM282 3mg
Cohort 3 - NGM282 1mg	Experimental	Biological: NGM282Cohort 3 - NGM282 1mg
Cohort 4 - Placebo	Placebo comparator	Other: PlaceboCohort 4 - Placebo
Cohort 4 - NGM282 1mg	Experimental	Biological: NGM282Cohort 4 - NGM282 1mg

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Males or females, between 18 and 75 years of age, inclusive
Histologically confirmed NASH diagnosis

Key exclusion criteria (2 listed)

Clinically significant acute or chronic liver disease
Prior liver transplantation

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
NGM282	Biological	Cohort 1 - NGM282 3mg, Cohort 1 - NGM282 6mg, Cohort 2 - NGM282 0.3mg, Cohort 2 - NGM282 1mg, Cohort 2 - NGM282 3mg, Cohort 3 - NGM282 1mg, Cohort 4 - NGM282 1mg
Placebo	Other	Cohort 1 - Placebo, Cohort 4 - Placebo

Primary outcome

Change in Absolute Liver Fat Content (Part 1)
Time frame: Up to Week 12
Absolute liver fat content was assessed using magnetic resonance imaging (MRI).
Change in Absolute Liver Fat Content (Part 2)
Time frame: Up to Week 12
Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Change in Absolute Liver Fat Content (Part 3)
Time frame: Up to Week 24
Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).

5 secondary outcomes

Percentage Change in Liver Fat Content (Part 1)
Time frame: Up to Week 12
Change in Absolute Liver Fat Content (Part 2)
Time frame: Up to Week 18
Percentage Change in Liver Fat Content (Part 2)
Time frame: Up to Week 18
Change in Absolute Liver Fat Content (Part 3)
Time frame: Up to Week 30
Percentage Change in Liver Fat Content (Part 3)
Time frame: Up to Week 30

Results and safety

Results posted to the registry on 26 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Aldafermin 3.0 mg	27	25
Part 1: Aldafermin 6.0 mg	28	24
Part 1: Placebo	27	23
Part 2: Aldafermin 0.3 mg	0	0
Part 2: Aldafermin 1.0 mg	0	0
Part 2: Aldafermin 3.0 mg	0	0
Part 2: Aldafermin 1.0 mg (Cohort 4)	0	0
Part 3: Aldafermin 1.0 mg	0	0
Part 3: Placebo	0	0

Primary outcome: Change in Absolute Liver Fat Content (Part 1)

Time frame: Up to Week 12. Least squares mean (Standard Error). Unit: percent of liver fat

Measure	Part 1: Aldafermin 3.0 mg n = 27	Part 1: Aldafermin 6.0 mg n = 28	Part 1: Placebo n = 27
Value	-9.68 (0.98)	-11.91 (1.00)	-0.85 (0.99)

Part 1: Aldafermin 3.0 mg vs Part 1: Placebo: Difference in least squares means: -8.84 (96% CI -12.09 to -5.59), p <0.001, t-test, 2 sided
Part 1: Aldafermin 6.0 mg vs Part 1: Placebo: Difference in least squares means: -11.06 (96% CI -14.39 to -7.74), p <0.001, t-test, 2 sided
Part 1: Aldafermin 3.0 mg vs Part 1: Aldafermin 6.0 mg: Difference in least squares means: -2.22 (96% CI -5.11 to 0.67), p = 0.112, t-test, 2 sided

Population analysed: Absolute liver fat content was assessed in participants with available data in the Efficacy Population.

Primary outcome: Change in Absolute Liver Fat Content (Part 2)

Time frame: Up to Week 12. Least squares mean (Standard Error). Unit: percent of liver fat

Measure	Part 2: Aldafermin 0.3 mg n = 23	Part 2: Aldafermin 1.0 mg n = 21	Part 2: Aldafermin 3.0 mg n = 20	Part 2: Aldafermin 1.0 mg (Cohort 4) n = 25
Value	-4.95 (1.07)	-10.69 (1.09)	-11.55 (1.08)	-10.85 (1.01)

Part 2: Aldafermin 0.3 mg vs Part 2: Aldafermin 1.0 mg: Difference in least squares means: -5.73 (95% CI -8.48 to -2.99), p <0.0001, t-test, 2 sided
Part 2: Aldafermin 0.3 mg vs Part 2: Aldafermin 3.0 mg: Difference in least squares means: -6.60 (95% CI -9.41 to -3.79), p <0.0001, t-test, 2 sided
Part 2: Aldafermin 1.0 mg vs Part 2: Aldafermin 3.0 mg: Difference in least squares means: -0.87 (95% CI -3.71 to 1.98), p = 0.5467, t-test, 2 sided

Population analysed: Absolute liver fat content was assessed in participants with available data in the Efficacy Population.

Primary outcome: Change in Absolute Liver Fat Content (Part 3)

Time frame: Up to Week 24. Least squares mean (Standard Error). Unit: percent of liver fat

Measure	Part 3: Aldafermin 1.0 mg n = 51	Part 3: Placebo n = 22
Value	-7.70 (0.82)	-2.73 (1.29)

Part 3: Aldafermin 1.0 mg vs Part 3: Placebo: Difference in least squares means: -4.97 (95% CI -8.03 to -1.91), p = 0.0018, t-test, 2 sided

Population analysed: Absolute liver fat content was assessed in participants with available data in the Efficacy Population.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Aldafermin 3.0 mg	1 of 27 (3.7%)	26 of 27 (96.3%)	0 of 27
Part 1: Aldafermin 6.0 mg	0 of 28 (0%)	27 of 28 (96.4%)	0 of 28
Part 1: Placebo	0 of 27 (0%)	23 of 27 (85.2%)	0 of 27
Part 2: Aldafermin 0.3 mg	0 of 23 (0%)	20 of 23 (87%)	0 of 23
Part 2: Aldafermin 1.0 mg	1 of 21 (4.8%)	19 of 21 (90.5%)	0 of 21
Part 2: Aldafermin 3.0 mg	4 of 22 (18.2%)	21 of 22 (95.5%)	0 of 22
Part 2: Aldafermin 1.0 mg (Cohort 4)	1 of 28 (3.6%)	27 of 28 (96.4%)	0 of 28
Part 3: Aldafermin 1.0 mg	2 of 53 (3.8%)	46 of 53 (86.8%)	0 of 53
Part 3: Placebo	3 of 25 (12%)	22 of 25 (88%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39326675Alkhouri N, Beyer C, Shumbayawonda E, Andersson A, Yale K, Rolph T, Chung RT, Vuppalanchi R, Cusi K, Loomba R, Pansini M, Dennis A. Decreases in cT1 and liver fat content reflect treatment-induced histological improvements in MASH. J Hepatol. 2025 Mar;82(3):438-445. doi: 10.1016/j.jhep.2024.08.031. Epub 2024 Sep 25.
Derived from this study: PubMed 36318027Nedrud MA, Chaudhry M, Middleton MS, Moylan CA, Lerebours R, Luo S, Farjat A, Guy C, Loomba R, Abdelmalek MF, Sirlin CB, Bashir MR. MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. Radiology. 2023 Mar;306(3):e220743. doi: 10.1148/radiol.220743. Epub 2022 Nov 1.
Derived from this study: PubMed 33898959Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun.
Derived from this study: PubMed 32794259Loomba R, Ling L, Dinh DM, DePaoli AM, Lieu HD, Harrison SA, Sanyal AJ. The Commensal Microbe Veillonella as a Marker for Response to an FGF19 Analog in NASH. Hepatology. 2021 Jan;73(1):126-143. doi: 10.1002/hep.31523. Epub 2020 Dec 11.
Derived from this study: PubMed 32781086Harrison SA, Neff G, Guy CD, Bashir MR, Paredes AH, Frias JP, Younes Z, Trotter JF, Gunn NT, Moussa SE, Kohli A, Nelson K, Gottwald M, Chang WCG, Yan AZ, DePaoli AM, Ling L, Lieu HD. Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Jan;160(1):219-231.e1. doi: 10.1053/j.gastro.2020.08.004. Epub 2020 Aug 8.
Derived from this study: PubMed 29519502Harrison SA, Rinella ME, Abdelmalek MF, Trotter JF, Paredes AH, Arnold HL, Kugelmas M, Bashir MR, Jaros MJ, Ling L, Rossi SJ, DePaoli AM, Loomba R. NGM282 for treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2018 Mar 24;391(10126):1174-1185. doi: 10.1016/S0140-6736(18)30474-4. Epub 2018 Mar 5.

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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.

NGM Study Director study director

NGM Biopharmaceuticals, Inc

22 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NGM282 in people with Nonalcoholic Steatohepatitis (NASH), run by NGM Biopharmaceuticals, Inc at 22 sites in 3 countries.

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 2 inclusion and 2 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Australia, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Absolute Liver Fat Content (Part 1) (time frame: Up to Week 12). The study lists 3 primary outcomes in all. 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 NCT02443116, which also lists 6 linked publications.

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 23 Jul 2025.