TERN-601 / Terns Pharma - LARVOL DELTA

FALCON: A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity (clinicaltrials.gov) - P2 | N=167 | Completed | Sponsor: Terns, Inc. | Trial completion date: Dec 2026 ➔ Sep 2025 | Trial primary completion date: Nov 2026 ➔ Aug 2025 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

Terns Pharmaceuticals Reports Topline 12-week Data from its Phase 2 Trial Evaluating Oral GLP-1 Receptor Agonist TERN-601 in Obesity (GlobeNewswire) - "The Phase 2 topline 12-week results for TERN-601 did not meet this threshold and likely preclude further development...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....Company will not advance TERN-601 or invest in other metabolic assets."

Discontinued • P2a data • Obesity

Pharmacodynamic effects of oral small molecule GLP-1 agonist TERN-601 in healthy participants with obesity or overweight (EASD 2025) - "This study showed that all doses of TERN-601 were pharmacologically active based on PD markers GLP-1R mechanism of action, which included reduced appetite scores, lower post-prandial glucose, insulin, and C-peptide levels, and slower gastric emptying. Together, these findings support the further clinical development of TERN-601 at doses of 240 mg QD and above for chronic weight management."

Clinical • PK/PD data • Metabolic Disorders • Obesity

FALCON: A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Terns, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Effect of Oral Small Molecule GLP-1 Receptor Agonist TERN-601 in Healthy Participants with Obesity or Overweight—A First-in-Human Study (ADA 2025) - "TERN-601 demonstrated favorable safety and tolerability in this FIH study in participants with obesity or overweight. TERN-601 led to clinically meaningful reductions in body weight. These results support further clinical development of TERN-601 for chronic weight management."

Clinical • P1 data • Metabolic Disorders • Obesity

No Effect of Food or Proton Pump Inhibitor on the Pharmacokinetics of TERN-601, an Oral Small Molecule GLP-1 Receptor Agonist (ADA 2025) - "TERN-601 appeared safe and well-tolerated. Neither food nor a PPI had clinically meaningful effects on the PK of TERN-601, supporting the administration of TERN-601 without restriction of food or acid reducing agents."

PK/PD data • Metabolic Disorders

Terns Pharmaceuticals Presents Positive Data from Phase 1 Study of TERN-601 Once-daily Oral GLP-1R Agonist for Treatment of Obesity at 85th Annual American Diabetes Association Scientific Sessions (GlobeNewswire) - P1 | N=NA | "Key highlights from the ADA presentation include: Efficacy: (i) Statistically significant and dose-dependent weight loss up to 5.5% over 28 days with QD dosing; (ii) Dose related increase in weight loss with 67% of patients losing 5% or more body weight at top dose; (iii) Unique pharmaceutical properties result in flat PK curve allowing 24hr target coverage with QD dosing and effective half-life of 9-10 hours; (iv) Higher gut vs. plasma exposures and low free fraction drives meaningful weight loss without sacrificing tolerability; Safety: (i) Well-tolerated despite rapid dose titration every three days; (ii) No treatment related interruptions, reductions, discontinuations at any dose..."

P1 data • Obesity

Terns Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Corporate Updates (GlobeNewswire) - "TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity:...The FALCON Phase 2 trial is ongoing with top-line 12-week data expected in 4Q 2025."

P2 data • Obesity

FALCON: A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Terns, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity (GlobeNewswire) - "The FALCON Phase 2 clinical trial enrolled its first patient in March 2025, with 12-week data expected in the fourth quarter of 2025"

P2 data • Obesity

FALCON: A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults with Overweight or Obesity (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Terns, Inc.

New P2 trial • Genetic Disorders • Obesity

TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity (GlobeNewswire) - "Terns announces design of the FALCON Phase 2 clinical trial, expected to initiate early in the second quarter of 2025 with 12-week data expected in the second half of 2025."

New P2 trial • Obesity

Terns Pharmaceuticals Announces First Participant Dosed in Phase 1 Clinical Trial of TERN-601 Oral GLP-1 Receptor Agonist for Treatment of Obesity (BioSpace) - "Terns Pharmaceuticals, Inc...announced that the first participant has been dosed in the Phase 1 clinical trial of TERN-601, the Company’s oral small-molecule glucagon-like peptide-1 receptor, or GLP-1R, agonist for the treatment of obesity....Top-line, proof of concept 28-day weight loss data from Part 2 (MAD) are expected in the second half of 2024."

P1 data • Trial status • Metabolic Disorders • Obesity

TERN-601, a Novel Oral GLP-1R Agonist, Suppresses Food Intake and Improves Glucose Tolerance in Transgenic Mice Expressing Human GLP-1 Receptor (ADA 2023) - "In an intraperitoneal glucose tolerance test (IPGTT) on overnight fasted hGLP-1R mice (n = 7 per group), single oral doses of TERN-601 (0.3, 1, and 3 mg/kg) administered 30 minutes prior to IP glucose injection significantly lowered blood glucose area under the curve (AUC0-120min) with comparable efficacy to liraglutide (0.3 mg/kg). In transgenic mice expressing human GLP-1R, single oral doses of TERN-601 significantly suppressed food intake and improved glucose tolerance. Together these data support the continued development of TERN-601."

Preclinical • Diabetes • Metabolic Disorders • Obesity