Terns Pharmaceuticals reports 12-week results from TERN-601 trial

Terns Pharmaceuticals (TERN) announced topline 12-week results from its Phase 2 trial of TERN-601, a novel, once-daily, oral GLP-1 receptor agonist as a potential treatment for obesity. Baseline characteristics were generally well-balanced across the treatment arms. Participants were predominantly female, mean age range was 47-53 years of age, with mean weight and body mass index ranges of 99-102 kg and 36-37 kg/m2, respectively. Statistically significant weight loss at doses greater than 500 mg. Of the 134 participants who received TERN-601, 11.9% and 8.2% discontinued treatment or had dose modification due to adverse events, respectively, the majority of which were gastrointestinal related. GI AEs were all mild or moderate, most commonly nausea, vomiting, constipation, diarrhea and appeared to be dose related. There were no severe GI AEs in any group; rates of GI AEs were overall stable over the treatment period. Across all participants, mean AST, ALT, alkaline phosphatase, and total bilirubin remained overall stable during the treatment period. No participants had dose interruption, reduction, or discontinuation due to abnormal liver function tests during the treatment period. Of 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. The LFT elevations in the third participant had an alternate etiology of gall stones and was 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.