Terns Pharmaceuticals (TERN) Study Result summary

Study Overview and Objectives

• Phase I trial of TERN-601, an oral, once-daily GLP-1 receptor agonist, conducted in overweight or obese, non-diabetic adults, included single and multiple ascending dose cohorts over 28 days.

• Explored a dose range of 100–740 mg, with all cohorts completing titration within two weeks and safety data guiding escalation.

• Primary endpoints were safety and tolerability; secondary endpoints included pharmacokinetics, pharmacodynamics, and weight change.

• All objective success metrics were met, including robust weight loss, dose escalation, and strong dose response.

• Manufacturing is scalable with low cost of goods, supporting broad patient access.

Key Efficacy and Safety Results

• Statistically significant, dose-dependent mean weight loss up to 5.5% from baseline (4.9% placebo-adjusted) over 28 days.

• 67% of subjects at the highest dose lost ≥5% body weight; robust dose-response observed.

• Meaningful improvements in hunger and satiety scores observed at all doses.

• No dose interruptions, reductions, or discontinuations due to adverse events; GI side effects were mild to moderate.

• Over 95% of treatment-emergent adverse events were mild; no severe or serious adverse events reported.

Pharmacokinetics and Pharmacodynamics

• Linear PK with proportional increases in exposure; flat PK curve achieved at ≥100 mg doses.

• Sustained target coverage for 16–24 hours at higher doses, supporting once-daily dosing.

• High gut permeability, low solubility, and high plasma protein binding led to prolonged absorption, high gut tissue concentrations, and a wide therapeutic window.

• No drug accumulation observed over 28 days; exposures remained stable.

• Evidence of on-target glycemic control and delayed gastric emptying at all dose levels.