On Tuesday, Terns Pharmaceuticals Inc. (NASDAQ:TERN) shared topline 12-week results from its FALCON Phase 2 trial of TERN-601.
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The therapy is an oral GLP-1 receptor agonist (GLP-1RA) as a potential treatment for obesity in adults without diabetes.
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Weight Loss
At a 250 mg dose, placebo-adjusted weight loss was 1.8%, which was not statistically significant with p=0.056.
At a 500 mg slow titration, weight loss was around 3.6% and 4.6% at a 500 mg dose.
Weight loss at 750 mg was around 3%.
Safety and Tolerability
Of the 134 participants who received TERN-601, 11.9% and 8.2% discontinued treatment or had dose modification due to adverse events (AEs), respectively, the majority of which were gastrointestinal (GI) related.
GI AEs were all mild or moderate, most commonly nausea (56%), vomiting (26.9%), constipation (11.9%), diarrhea (9.7%), and appeared to be dose related.
Across all participants, mean AST, ALT, alkaline phosphatase, and total bilirubin remained overall stable during the treatment period.
Of the three participants who had grade 3 LFT elevations during the post-treatment follow-up, two participants in the 500 mg treatment arm had profiles consistent with drug-induced liver injury (DILI) (one supported by findings on liver biopsy).
The LFT elevations in the third participant (750 mg) had an alternate etiology of gallstones and were deemed unlikely to be drug-related by the investigator, although DILI could not be definitively ruled out.
The investigator-reported assessments for all three participants agreed with the independent adjudication of the three cases by a DILI Network expert clinician.
TERN Price Action: Terns Pharma shares were down 3.33% at $7.85 at the time of publication on Wednesday, according to Benzinga Pro data.
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