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Core Insights - Terns Pharmaceuticals, Inc. has announced the topline results of its Phase 2 clinical trial for TERN-601, an oral GLP-1 receptor agonist aimed at treating obesity [2][6] Group 1: Key Trial Results - Participants using doses above 500 mg experienced a maximum placebo-adjusted weight loss of 4.6%, with statistically significant weight loss observed at higher doses [3] - Weight loss results by dosage: - TERN-601 250 mg: -1.8% placebo-adjusted - TERN-601 500 mg (slow titration): -3.6% placebo-adjusted - TERN-601 500 mg: -4.6% placebo-adjusted - TERN-601 750 mg: -3.0% placebo-adjusted - Placebo: No significant weight loss observed - p-values for 500 mg and 750 mg doses were below 0.01, indicating statistical significance [3] Group 2: Safety Profile - 12% of participants discontinued treatment due to adverse events (AEs), primarily gastrointestinal issues, with nausea being the most common [4] - Gastrointestinal AEs were generally mild to moderate, including nausea (56%), vomiting (26.9%), constipation (11.9%), and diarrhea (9.7%), and were dose-related but did not result in severe cases [4] - Three participants experienced grade 3 liver enzyme elevations post-treatment, with two possibly related to the drug, consistent with drug-induced liver injury (DILI) [4] Group 3: Strategic Shift - Despite some treatment groups showing weight loss effects, the trial results did not meet the high standards for safety, efficacy, and tolerability required for a differentiated oral GLP-1RA treatment [6] - Consequently, Terns Pharmaceuticals has decided to discontinue the development of TERN-601 and will not pursue further investments in metabolic diseases [6] - The company will refocus on TERN-701, an allosteric BCR-ABL inhibitor for chronic myeloid leukemia (CML), with confidence in the ongoing Phase 1 CARDINAL trial and expects to release related data this quarter [6]