Hoth Therapeutics Inc. (NASDAQ:HOTH) on Tuesday revealed preclinical data from its study on glial cell-derived neurotrophic factor (GDNF) for obesity and metabolic-associated steatotic liver disease (MASLD).

The U.S. Veterans Administration (VA) backed the study, which builds on prior research showing GDNF's protective role against diet-induced obesity.

In a head-to-head comparison, GDNF demonstrated superior efficacy over semaglutide in key metrics, including weight stabilization, glucose tolerance, liver weight reduction, and adipose tissue control—particularly in female models.

Semaglutide is the active ingredient in Novo Nordisk A/S' (NYSE:NVO) Wegovy and Ozempic️.

The company on Tuesday exclusively told Benzinga that the update positions GDNF as a potential game-changer in the $200 billion obesity market, offering a differentiated mechanism that could address limitations of current GLP-1 agonists like gastrointestinal side effects and muscle loss.

With obesity affecting over 1 billion people globally and MASLD impacting up to 30% of adults, GDNF's multi-faceted benefits could revolutionize treatment paradigms.

Key Study Highlights:

In female mice on a high-fat Western diet, GDNF attenuated weight gain by 10-15%, leading to a plateau in the final weeks of treatment—unlike semaglutide, which showed no significant impact.

Researchers noted that higher doses or longer durations could amplify GDNF's effects, suggesting even greater potential for sustained weight loss.

GDNF fully normalized fasting glucose and improved overall response to glucose challenges, outperforming semaglutide in females. Baseline improvements were also seen in males, indicating broad metabolic benefits.

GDNF reduced liver weight by 20-30% and prevented adipose tissue accumulation in females, surpassing semaglutide's effects.

What Next?

Future analyses will include liver pathology, lipid content, and gene/protein expression to further elucidate mechanisms. Hoth plans to accelerate GDNF toward IND-enabling studies, targeting clinical trials in 2027.

Hoth's GDNF program is part of a pipeline, including HT-001 (Phase 2 for cancer-related skin toxicities), HT-KIT (Orphan Drug Designation for mast cell cancers), and HT-ALZ (for Alzheimer's).

In January, Hoth Therapeutics shared interim results from the open-label pharmacokinetic (PK) cohort of its ongoing CLEER-001 trial evaluating HT-001 in cancer patients receiving EGFR inhibitor therapy.

In the open-label PK cohort, 100% of evaluable patients achieved clinical response by Week 6, accompanied by an approximate 50% reduction in investigator-assessed disease severity (using the ARIGA scale) from baseline.

HOTH Price Action: Hoth Therapeutics shares were up 1.83% at $0.87 during premarket trading on Tuesday, according to Benzinga Pro data.

Photo by shisu_ka via Shutterstock

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