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
Phase 1 clinical study of TERN-601 demonstrated differentiated profile in 28-day study; topline data were presented in September 2024
Phase 2 FALCON clinical trial of TERN-601 completed enrollment; 12-week data expected in 4Q 2025
FOSTER CITY, CA, USA I June 23, 2025 I Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced that data from the completed Phase 1 study of TERN-601, a novel once-daily oral GLP-1R agonist, will be highlighted at the American Diabetes Association (ADA) 85th Scientific Sessions, taking place June 20-23, 2025, in Chicago, IL.
“We are thrilled to be selected for an oral presentation at ADA to highlight additional data from the 28-day Phase 1 study of TERN-601 demonstrating its differentiated profile among oral GLP1-R agonists,” said Amy Burroughs, chief executive officer of Terns. “In addition, we are pleased to share the recent completion of enrollment for our Phase 2 FALCON trial where the key objectives of the trial are to demonstrate TERN-601’s competitive weight loss at 12-weeks, a class leading safety and tolerability profile, and the simplest dose titration amongst GLP-1R agonist therapies.”
Topline data from the Phase 1 clinical study being presented at ADA were reported in September 2024 and provided the recommended doses taken forward in the ongoing Phase 2 FALCON study, which recently completed enrollment, with topline data expected in the fourth quarter of 2025.
Key highlights from the ADA presentation include:
Efficacy
Statistically significant and dose-dependent weight loss up to 5.5% over 28 days with QD dosing
Dose related increase in weight loss with 67% of patients losing 5% or more body weight at top dose
Unique pharmaceutical properties result in flat PK curve allowing 24hr target coverage with QD dosing and effective half-life of 9-10 hours
Higher gut vs. plasma exposures and low free fraction drives meaningful weight loss without sacrificing tolerability
Safety
Well-tolerated despite rapid dose titration every three days
No treatment related interruptions, reductions, discontinuations at any dose
>95% of GI AEs were mild despite rapid titration
No meaningful changes in liver enzymes, vital signs or ECGs
Tolerability and ease of use
Simplest dose titration amongst GLP1-RA therapies
Dosing with or without food
Can be administered with PPIs, H2RA and/or antacids
The presentations and viewing detail are listed below:
Presentation Title:
Effect of Oral Small Molecule GLP-1 Receptor Agonist TERN-601 in Healthy Participants with Obesity or Overweight – A First-in-Human Study
Abstract Number:
307-OR
Presentation Date and Time:
Monday, June 23, 2025; 2:30-2:45 PM CT
Session Name:
Early Phase, Post Hoc, and Subgroup Analyses from Clinical Trials with lncretin-Based Therapies-Take 2
Presenter:
Cara H. Nelson, Terns Pharmaceuticals, Foster City, CA, USA
Presentation Title:
No Effect of Food or Proton Pump Inhibitor on the Pharmacokinetics of TERN-601, an Oral Small Molecule GLP-1 Receptor Agonist
Abstract Number:
767-P
Presentation Date and Time:
Sunday Jun 22, 2025; 12:30 PM – 1 :30 PM CT
Session Name:
Clinical Therapeutics-lncretin-Based Therapies
Presenter:
Cara H. Nelson, Terns Pharmaceuticals, Foster City, CA, USA
About the TERN-601 Phase 1 Trial
The Phase 1 trial was a randomized, double-blind, placebo-controlled single and multiple-ascending dose (SAD and MAD) trial to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TERN-601 in healthy adults with obesity or overweight. The trial consisted of two parts.
Part 1 (SAD) was a single ascending dose study that evaluated five TERN-601 dose levels in healthy participants with a Body Mass Index (BMI) of ≥ 25 kg/m2 and < 40 kg/m2. The starting TERN-601 dose was 30 mg, with subsequent dose levels based on review of emerging safety and PK data from prior cohorts.
In Part 2 (MAD) of the trial, obese and overweight healthy adults were enrolled in cohorts that included titration of TERN-601 administered for 28 days at doses selected based on data from Part 1 (SAD). Part 2 included healthy participants with a BMI of ≥ 27 kg/m2 to < 40 kg/m2.
The primary endpoint of the trial was to evaluate safety and tolerability of TERN-601 administered once-daily for 28 days. Secondary endpoints included PK, efficacy as measured by body weight loss following 28 days of treatment with TERN-601, and other exploratory markers.
About FALCON Phase 2 Trial
FALCON is an ongoing U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601, with once-daily dosing with or without food in adults with obesity or who are overweight, without diabetes (BMI ranges from ≥30 to <50 kg/m2 or ≥27 to <30 kg/m2 with at least one weight-related comorbidity). Patients are randomized to one of four active cohorts (n=30 per cohort): 250 mg, 500 mg, 500 mg slow titration, 750 mg or placebo. The primary endpoint is percent change from baseline in body weight compared to placebo over 12 weeks and secondary endpoints include safety, tolerability and proportion of patients achieving 5% weight loss or greater.
About Terns Pharmaceuticals
Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1 receptor agonist, a THR-β agonist, and a preclinical GIPR modulator discovery effort, prioritizing a GIPR antagonist nomination candidate. For more information, please visit: www.ternspharma.com.
Phase 1 clinical study of TERN-601 demonstrated differentiated profile in 28-day study; topline data were presented in September 2024
Phase 2 FALCON clinical trial of TERN-601 completed enrollment; 12-week data expected in 4Q 2025
FOSTER CITY, CA, USA I June 23, 2025 I Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced that data from the completed Phase 1 study of TERN-601, a novel once-daily oral GLP-1R agonist, will be highlighted at the American Diabetes Association (ADA) 85th Scientific Sessions, taking place June 20-23, 2025, in Chicago, IL.
“We are thrilled to be selected for an oral presentation at ADA to highlight additional data from the 28-day Phase 1 study of TERN-601 demonstrating its differentiated profile among oral GLP1-R agonists,” said Amy Burroughs, chief executive officer of Terns. “In addition, we are pleased to share the recent completion of enrollment for our Phase 2 FALCON trial where the key objectives of the trial are to demonstrate TERN-601’s competitive weight loss at 12-weeks, a class leading safety and tolerability profile, and the simplest dose titration amongst GLP-1R agonist therapies.”
Topline data from the Phase 1 clinical study being presented at ADA were reported in September 2024 and provided the recommended doses taken forward in the ongoing Phase 2 FALCON study, which recently completed enrollment, with topline data expected in the fourth quarter of 2025.
Key highlights from the ADA presentation include:
Efficacy
Statistically significant and dose-dependent weight loss up to 5.5% over 28 days with QD dosing
Dose related increase in weight loss with 67% of patients losing 5% or more body weight at top dose
Unique pharmaceutical properties result in flat PK curve allowing 24hr target coverage with QD dosing and effective half-life of 9-10 hours
Higher gut vs. plasma exposures and low free fraction drives meaningful weight loss without sacrificing tolerability
Safety
Well-tolerated despite rapid dose titration every three days
No treatment related interruptions, reductions, discontinuations at any dose
>95% of GI AEs were mild despite rapid titration
No meaningful changes in liver enzymes, vital signs or ECGs
Tolerability and ease of use
Simplest dose titration amongst GLP1-RA therapies
Dosing with or without food
Can be administered with PPIs, H2RA and/or antacids
The presentations and viewing detail are listed below:
Presentation Title:
Effect of Oral Small Molecule GLP-1 Receptor Agonist TERN-601 in Healthy Participants with Obesity or Overweight – A First-in-Human Study
Abstract Number:
307-OR
Presentation Date and Time:
Monday, June 23, 2025; 2:30-2:45 PM CT
Session Name:
Early Phase, Post Hoc, and Subgroup Analyses from Clinical Trials with lncretin-Based Therapies-Take 2
Presenter:
Cara H. Nelson, Terns Pharmaceuticals, Foster City, CA, USA
Presentation Title:
No Effect of Food or Proton Pump Inhibitor on the Pharmacokinetics of TERN-601, an Oral Small Molecule GLP-1 Receptor Agonist
Abstract Number:
767-P
Presentation Date and Time:
Sunday Jun 22, 2025; 12:30 PM – 1 :30 PM CT
Session Name:
Clinical Therapeutics-lncretin-Based Therapies
Presenter:
Cara H. Nelson, Terns Pharmaceuticals, Foster City, CA, USA
About the TERN-601 Phase 1 Trial
The Phase 1 trial was a randomized, double-blind, placebo-controlled single and multiple-ascending dose (SAD and MAD) trial to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TERN-601 in healthy adults with obesity or overweight. The trial consisted of two parts.
Part 1 (SAD) was a single ascending dose study that evaluated five TERN-601 dose levels in healthy participants with a Body Mass Index (BMI) of ≥ 25 kg/m2 and < 40 kg/m2. The starting TERN-601 dose was 30 mg, with subsequent dose levels based on review of emerging safety and PK data from prior cohorts.
In Part 2 (MAD) of the trial, obese and overweight healthy adults were enrolled in cohorts that included titration of TERN-601 administered for 28 days at doses selected based on data from Part 1 (SAD). Part 2 included healthy participants with a BMI of ≥ 27 kg/m2 to < 40 kg/m2.
The primary endpoint of the trial was to evaluate safety and tolerability of TERN-601 administered once-daily for 28 days. Secondary endpoints included PK, efficacy as measured by body weight loss following 28 days of treatment with TERN-601, and other exploratory markers.
About FALCON Phase 2 Trial
FALCON is an ongoing U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601, with once-daily dosing with or without food in adults with obesity or who are overweight, without diabetes (BMI ranges from ≥30 to <50 kg/m2 or ≥27 to <30 kg/m2 with at least one weight-related comorbidity). Patients are randomized to one of four active cohorts (n=30 per cohort): 250 mg, 500 mg, 500 mg slow titration, 750 mg or placebo. The primary endpoint is percent change from baseline in body weight compared to placebo over 12 weeks and secondary endpoints include safety, tolerability and proportion of patients achieving 5% weight loss or greater.
About Terns Pharmaceuticals
Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1 receptor agonist, a THR-β agonist, and a preclinical GIPR modulator discovery effort, prioritizing a GIPR antagonist nomination candidate. For more information, please visit: www.ternspharma.com.
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