Tesamorelin Fatty Liver Trial: What It Found

Tesamorelin was associated with lower liver fat after a year in a small trial of adults with HIV, a virus that weakens the immune system. The 2019 tesamorelin fatty liver study found a 4.1-percentage-point greater drop than placebo, an inactive injection. It also found less worsening of liver scarring. Those results do not establish the same benefit for everyone with fatty liver.

What did the tesamorelin fatty liver trial ask?

The question was straightforward: could tesamorelin lower liver fat in people with HIV and fatty liver disease?

Tesamorelin prompts the pituitary, a small gland below the brain, to release growth hormone. This hormone helps regulate how the body uses fat. Researchers wanted to see whether that action mattered inside the liver.

The paper used NAFLD, short for nonalcoholic fatty liver disease. The 2023 naming consensus introduced MASLD: liver fat linked to at least one metabolic risk, such as high blood sugar. The newer name doesn't change who joined this older study.

Who joined, and for how long?

Takara Stanley and colleagues reported the trial in The Lancet HIV in 2019. It enrolled 61 adults at Massachusetts General Hospital and the National Institutes of Health. Eligible ages were 18–70; participants averaged their early 50s, and most were men.

Everyone had controlled HIV, stable HIV treatment, and liver fat of at least 5%. People with heavy alcohol use, hepatitis B, or active hepatitis C, both viral liver infections, were excluded. Cirrhosis, meaning advanced liver scarring, was also an exclusion.

Random assignment put 31 people in the tesamorelin group and 30 in the placebo group. They received daily injections for 12 months. Participants and researchers didn't know which treatment each person received. The registry record, NCT02196831, documents the study.

What did researchers measure?

The main measure was liver-fat fraction: the share of the liver made up of fat. Researchers used magnetic resonance spectroscopy, a scan that estimates liver fat.

They also took liver biopsies, small tissue samples, to check scarring and inflammation. These answered a different question from the fat scan.

Follow-up data from 54 participants entered the main analysis. Fewer had complete 12-month scans or paired biopsies. This was a small study, with some missing follow-up measurements.

What were the results after 12 months?

The headline result was a 4.1-percentage-point greater reduction in liver fat with tesamorelin than with placebo. The trial's estimated range of uncertainty was 0.7–7.6 points.

The paper also reported a 37% relative treatment effect. That describes the difference in proportional liver-fat change between the groups. It isn't the amount every participant lost.

About one in three tesamorelin participants, 35%, finished below the study's 5% liver-fat threshold. Only 4% of placebo participants reached that threshold. Crossing it doesn't establish that scarring or other liver problems have resolved.

Fibrosis, the medical word for scarring, worsened in 2 of 19 people (10.5%) receiving tesamorelin, versus 9 of 24 (37.5%) receiving placebo. These were the participants with biopsies at both time points. Scarring was a secondary measure, rather than the trial's main question.

Existing scarring did not clearly improve more with tesamorelin. Overall liver inflammation and body weight also showed no clear difference between groups. The study didn't establish fewer cases of liver failure or longer life.

What side effects appeared in the paper?

The paper's safety table counted people reporting an event. A person could appear in several rows. These counts don't establish that tesamorelin caused every event.

None of the serious events was judged related to the study drug. Average blood-sugar measurements did not clearly differ between groups. Still, two tesamorelin participants stopped treatment because blood sugar worsened. One already had diabetes. A reassuring group average doesn't remove an individual's risk.

What did critics and later studies add?

An accompanying Lancet HIV commentary by Jennifer Audsley and colleagues questioned long-term safety. They also asked whether liver fat would stay lower after treatment stopped.

A 2020 JCI Insight substudy examined gene expression, meaning which genes liver cells actively use. It found changes involving energy production, inflammation, and scarring pathways. Those samples came from the same trial. They offer clues about how tesamorelin works, rather than independent proof of lasting benefit.

As of September 30, 2026, the day this article was written, a review published July 31, 2026 combined four trials involving 909 people with HIV. It supported an association with less visceral fat, the fat around abdominal organs. That review strengthens the abdominal-fat evidence; it doesn't establish a liver treatment for the general population.

As of September 30, 2026, the day this article was written, a separate 51-person fatty-liver study, NCT03375788, had posted results, first released November 20, 2025. Its protocol excluded HIV. Reported middle values showed liver fat falling with tesamorelin and rising with placebo. This adds evidence in people with obesity through investigator-posted registry results, rather than a journal paper.

What does this mean for Egrifta and a blend?

The Egrifta WR label, revised March 2025, covers excess abdominal fat in adults with HIV-associated lipodystrophy, a change in fat distribution. Fatty liver is not its listed indication.

Tesamorelin through Promise is dispensed as a compounded medication, which is different from an FDA-approved product: the formulation offered here is not FDA-approved. A licensed provider may still prescribe a compounded formulation; that decision is between the patient and the doctor.

The 2019 trial studied tesamorelin alone. A tesamorelin-ipamorelin blend adds a second compound. The trial’s liver results cannot be assigned to that blend or assumed for a compounded formulation.

As of September 30, 2026, the day this article was written, an August 24 FDA warning letter identified online tesamorelin and tesamorelin-ipamorelin products as unapproved new drugs. It addressed those specific products and their claims.

What belongs in a provider conversation?

A prescribed route gives the patient an accountable prescriber and a licensed U.S. pharmacy. A pharmacy label identifies the contents, and pharmacy records allow a batch to be traced. There is also a contact for reporting problems. Those practical checks matter when a trial result appears beside an online product.

The useful starting point is the diagnosis: how much liver fat is present, whether there is scarring, and what other conditions need attention. The Egrifta label calls for monitoring blood sugar and IGF-1, a hormone that carries growth signals. A prescriber sets the actual dose and follow-up plan.

For other liver studies, see semaglutide for fatty liver and tirzepatide for fatty liver. Their findings come from different study populations. Our tesamorelin clinical trials guide puts this liver study alongside the abdominal-fat trials.

At Promise, a licensed provider reviews every request, and not everyone qualifies.