Phase 3 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT07165028 Sponsor: Eli Lilly and Company Condition: Non-Alcoholic Fatty Liver Disease
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Phase 3 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT07165028
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Your liver contains a certain level of fat (at least 8%), which would be measured before joining (confirm with trial site)
  • A specific liver health score called an ELF score falls within a certain range, suggesting a moderate level of liver scarring or damage (confirm with trial site)
  • A scan measuring the stiffness of your liver shows results within a specific range, suggesting a certain level of liver scarring (confirm with trial site)

Who may not be able to join:

  • You have a liver disease other than a condition called MASLD (a type of fatty liver disease related to metabolism)
  • Your body weight is considered lower than a certain threshold relative to your height (a BMI under 25)
  • You have had serious liver complications in the past, such as swollen veins in the throat or stomach, fluid build-up in the belly, or episodes of confusion caused by liver problems
  • You have lost more than 11 pounds in the 3 months before joining the trial
  • A blood test shows your average blood sugar levels over the past few months are above a certain high level (HbA1c greater than 10%)
  • You have Type 1 diabetes

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Phone: 1-317-615-4559

Australian sites

Nightingale Research, Adelaide,
Flinders Medical Centre, Adelaide,
Box Hill Hospital, Box Hill,
+ 61 3 9094 9555
Royal Brisbane and Women's Hospital, Brisbane,
+61 7 36468111
Core Research Group, Brisbane,
61738765688
Mater Misericordiae Limited, Brisbane,
Gallipoli Medical Research Ltd, Brisbane,
0733947284
Genesis Research Services, Broadmeadow,
Austin Health, Heidelberg,
61 3 9496 2787
Ipswich Hospital, Ipswich,
0402112100
Fiona Stanley Hospital, Murdoch,
TrialsWest - Osborne Park, Osborne Park,
The Royal Melbourne Hospital, Parkville,
Gold Coast University Hospital, Southport,
Westmead Hospital, Westmead,
0288907705

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
15 October 2025
Est. completion
1 August 2030

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇿 New Zealand 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal Puerto Rico 🇷🇴 Romania 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

15 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov