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
Terns Pharmaceuticals (NASDAQ:TERN) presented positive Phase 1 data for TERN-601, their novel once-daily oral GLP-1R agonist for obesity treatment, at the 85th ADA Scientific Sessions. The 28-day study demonstrated significant dose-dependent weight loss up to 5.5%, with 67% of patients losing 5% or more body weight at the top dose.
The drug showed a differentiated safety profile with no treatment-related interruptions and over 95% of GI adverse events being mild, despite rapid dose titration. TERN-601 features unique pharmaceutical properties allowing 24-hour target coverage and can be administered with or without food and various acid-reducing medications.
The company also announced completion of enrollment for their Phase 2 FALCON trial, with 12-week topline data expected in Q4 2025.
Terns Pharmaceuticals (NASDAQ:TERN) ha presentato dati positivi di Fase 1 per TERN-601, il loro nuovo agonista orale GLP-1R somministrato una volta al giorno per il trattamento dell'obesità, durante la 85ª Sessione Scientifica ADA. Lo studio di 28 giorni ha mostrato una perdita di peso significativa e dose-dipendente fino al 5,5%, con il 67% dei pazienti che ha perso il 5% o più del peso corporeo alla dose più alta.
Il farmaco ha evidenziato un profilo di sicurezza differenziato senza interruzioni legate al trattamento e oltre il 95% degli eventi avversi gastrointestinali è stato lieve, nonostante una rapida titolazione della dose. TERN-601 presenta proprietà farmacologiche uniche che garantiscono una copertura del target per 24 ore e può essere somministrato con o senza cibo e insieme a diversi farmaci che riducono l'acidità gastrica.
L'azienda ha inoltre annunciato il completamento dell'arruolamento per lo studio di Fase 2 FALCON, con dati principali a 12 settimane attesi nel quarto trimestre 2025.
Terns Pharmaceuticals (NASDAQ:TERN) presentó datos positivos de la Fase 1 para TERN-601, su nuevo agonista oral GLP-1R de administración diaria para el tratamiento de la obesidad, en las 85ª Sesiones Científicas de la ADA. El estudio de 28 días mostró una pérdida de peso significativa y dependiente de la dosis de hasta el 5,5%, con un 67% de los pacientes perdiendo un 5% o más del peso corporal en la dosis más alta.
El medicamento mostró un perfil de seguridad diferenciado sin interrupciones relacionadas con el tratamiento y más del 95% de los eventos adversos gastrointestinales fueron leves, a pesar de la rápida titulación de la dosis. TERN-601 presenta propiedades farmacéuticas únicas que permiten una cobertura del objetivo durante 24 horas y puede administrarse con o sin alimentos y junto con diversos medicamentos reductores de ácido.
La compañía también anunció la finalización del reclutamiento para su ensayo Fase 2 FALCON, con datos principales a 12 semanas esperados en el cuarto trimestre de 2025.
Terns Pharmaceuticals (NASDAQ:TERN)는 85회 ADA 과학 세션에서 비만 치료를 위한 새로운 경구용 GLP-1R 작용제인 TERN-601의 긍정적인 1상 데이터를 발표했습니다. 28일간의 연구에서 용량 의존적으로 최대 5.5%의 유의미한 체중 감소가 나타났으며, 최고 용량에서는 67%의 환자가 체중의 5% 이상을 감량했습니다.
이 약물은 빠른 용량 증량에도 불구하고 치료 관련 중단 없이 차별화된 안전성 프로필을 보였으며, 위장관 부작용의 95% 이상이 경미했습니다. TERN-601은 24시간 목표 부위 커버리지를 가능하게 하는 독특한 약학적 특성을 가지고 있으며, 음식 섭취 여부와 다양한 산 감소 약물과 함께 투여할 수 있습니다.
회사 측은 또한 2상 FALCON 임상시험의 등록 완료를 발표했으며, 12주 주요 데이터는 2025년 4분기에 발표될 예정입니다.
Terns Pharmaceuticals (NASDAQ:TERN) a présenté des données positives de Phase 1 pour TERN-601, leur nouvel agoniste oral GLP-1R à prise quotidienne unique pour le traitement de l'obésité, lors des 85èmes Sessions Scientifiques de l'ADA. L'étude de 28 jours a démontré une perte de poids significative dépendante de la dose allant jusqu'à 5,5%, avec 67 % des patients perdant 5 % ou plus de leur poids corporel à la dose maximale.
Le médicament a montré un profil de sécurité différencié sans interruptions liées au traitement et plus de 95 % des effets indésirables gastro-intestinaux étaient légers, malgré une titration rapide de la dose. TERN-601 possède des propriétés pharmaceutiques uniques permettant une couverture ciblée sur 24 heures et peut être administré avec ou sans nourriture ainsi qu'avec divers médicaments réduisant l'acidité.
L'entreprise a également annoncé la fin du recrutement pour leur essai de Phase 2 FALCON, avec des données principales à 12 semaines attendues au quatrième trimestre 2025.
Terns Pharmaceuticals (NASDAQ:TERN) stellte positive Phase-1-Daten für TERN-601 vor, ihren neuartigen einmal täglich oral einzunehmenden GLP-1R-Agonisten zur Behandlung von Adipositas, auf den 85. ADA Wissenschaftlichen Sitzungen. Die 28-tägige Studie zeigte einen signifikanten dosisabhängigen Gewichtsverlust von bis zu 5,5%, wobei 67 % der Patienten bei der höchsten Dosis 5 % oder mehr ihres Körpergewichts verloren.
Das Medikament zeigte ein differenziertes Sicherheitsprofil ohne behandlungsbedingte Unterbrechungen, und über 95 % der gastrointestinalen Nebenwirkungen waren mild, trotz schneller Dosistitration. TERN-601 verfügt über einzigartige pharmazeutische Eigenschaften, die eine 24-stündige Zielabdeckung ermöglichen und kann mit oder ohne Nahrung sowie zusammen mit verschiedenen säurereduzierenden Medikamenten eingenommen werden.
Das Unternehmen gab zudem den Abschluss der Rekrutierung für die Phase-2-Studie FALCON bekannt, mit Topline-Daten nach 12 Wochen, die im vierten Quartal 2025 erwartet werden.
- Significant dose-dependent weight loss of up to 5.5% over just 28 days
- 67% of patients achieved 5%+ body weight loss at top dose
- Excellent safety profile with >95% of GI adverse events being mild
- Flexible administration with or without food and acid-reducing medications
- Simple dose titration compared to other GLP-1R agonist therapies
- Phase 2 FALCON trial enrollment completed ahead of Q4 2025 data readout
- None.
Insights
Terns' oral GLP-1 drug TERN-601 shows promising Phase 1 data with 5.5% weight loss in 28 days and favorable safety profile.
The Phase 1 data for TERN-601 represents a potentially significant advancement in the highly competitive GLP-1 receptor agonist market. The 5.5% weight loss achieved in just 28 days with once-daily oral dosing is particularly noteworthy, especially with 67% of patients losing 5%+ body weight at the highest dose. This efficacy rivals or exceeds early data from some injectable GLP-1 therapies in similar timeframes.
What differentiates TERN-601 from other oral GLP-1 candidates is its unique pharmaceutical properties that enable 24-hour target coverage with once-daily dosing and an effective half-life of 9-10 hours. The flat PK curve suggests consistent drug exposure throughout the day, potentially enabling better efficacy and tolerability balance. The higher gut versus plasma exposures and low free fraction appear to drive meaningful weight loss without sacrificing tolerability.
The safety and tolerability profile appears particularly strong - no treatment-related interruptions or discontinuations despite rapid dose titration every three days, with over 95% of gastrointestinal adverse events rated as mild. This contrasts favorably with other GLP-1 therapies where GI side effects often lead to discontinuation or dose reduction.
From a convenience perspective, TERN-601's ability to be taken with or without food and alongside acid-reducing medications (PPIs, H2RAs, antacids) represents a significant practical advantage over some competing therapies. With Phase 2 FALCON trial enrollment complete and data expected in Q4 2025, TERN-601 is positioning itself as a potentially differentiated player in the rapidly expanding obesity treatment landscape.
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, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- 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 losing5% 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
- Statistically significant and dose-dependent weight loss up to
- 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
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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This press release contains forward-looking statements about the Company within the meaning of the federal securities laws. Forward-looking statements include statements related to or in connection with the novelty and growth of the Company’s intellectual property portfolio; expectations, timing and potential results of the clinical trials and other development activities of the Company and its partners, including with respect to the FALCON trial; the potential indications to be targeted by the Company with its small-molecule product candidates; the therapeutic potential of the Company’s small-molecule product candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company’s product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company’s clinical trials; the potential differentiation of the Company’s small-molecule product candidates compared to similar or competitive products or product candidates; the Company’s clinical development plans and activities, including the results of any interactions with regulatory authorities on its programs; the Company’s expectations regarding the profile of its product candidates, including efficacy, tolerability, safety, metabolic stability and pharmacokinetic profile and potential differentiation as compared to other products or product candidates; the Company’s plans for and ability to continue to execute on its current development strategy, including potential combinations involving multiple product candidates; and the Company’s expectations with regard to its cash runway and sufficiency of its cash resources. All statements other than statements of historical facts contained in this press release, including statements regarding the Company’s strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “believe, “develop”, “expect”, and “objective” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
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FAQ
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