Terns Pharmaceuticals (TERN) Study Result summary

Study Overview and Objectives

• Phase I trial of TERN-601, an oral, once-daily GLP-1 receptor agonist, focused on overweight or obese, primarily non-diabetic adults, mostly male, over 28 days.

• The study included single and multiple ascending dose cohorts (100–740 mg), with rapid titration to high doses to assess safety, tolerability, and pharmacodynamic effects.

• All cohorts completed titration within two weeks, with safety data guiding escalation.

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

• Manufacturing is highly scalable with low cost of goods, supporting global access.

Efficacy Results

• Statistically significant, dose-dependent mean weight loss up to 5.5% from baseline (4.9% placebo-adjusted) at 28 days; 67% of subjects at top dose lost ≥5% body weight.

• All target doses were active, with a clear dose response: 2%, 4%, and 5% placebo-adjusted weight loss at 240, 500, and 740 mg, respectively.

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

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

• Distinct drug properties enabled sustained target coverage and a flat PK curve.

Safety and Tolerability

• Well tolerated with no drug-related discontinuations, interruptions, or dose reductions; over 95% of treatment-emergent adverse events were mild.

• No severe or serious adverse events reported; majority of GI-related adverse events were mild, even with fast titration.

• No clinically meaningful changes in liver enzymes, vital signs, ECGs, or heart rate at any dose; hepatic safety profile was excellent.

• GI AEs increased with faster titration but were manageable and did not lead to discontinuations.

• Safety profile consistent with known effects of GLP-1R agonist class.