Terns Pharmaceuticals Reports Topline 12-week Data from its Phase 2 Trial Evaluating Oral GLP-1 Receptor Agonist TERN-601 in Obesity
Terns (NASDAQ: TERN) announced topline 12-week Phase 2 results for oral GLP-1RA TERN-601 on October 21, 2025. The trial showed up to 4.6% placebo-adjusted weight loss at doses >500 mg but did not meet the company’s threshold for a differentiated oral GLP-1RA and likely precludes further development. Safety findings included mainly mild-to-moderate GI adverse events (nausea 56%, vomiting 26.9%) and three post-treatment grade 3 liver enzyme elevations, two adjudicated as drug related. Terns will not advance TERN-601 or invest further in metabolic assets and will focus on TERN-701 for CML, with clinical data expected this quarter.
Terns (NASDAQ: TERN) ha annunciato i risultati topline della fase 2 di 12 settimane per l'ole GLP-1RA TERN-601 il 21 ottobre 2025. Il trial ha mostrato una perdita di peso aggiustata per placebo fino al 4,6% a dosi >500 mg ma non ha soddisfatto la soglia dell'azienda per un GLP-1RA orale differenziato e probabilmente esclude ulteriori sviluppi. Le valutazioni di sicurezza hanno incluso principalmente eventi avversi gastrointestinali da lievi a moderati (nausea 56%, vomito 26,9%) e tre innalzamenti di enzimi epatici di grado 3 dopo il trattamento, due dei quali valutati come correlati al farmaco. Terns non avanzerà con TERN-601 né investirà ulteriormente in asset metabolici e si concentrerà su TERN-701 per la CML, con dati clinici attesi in questo trimestre.
Terns (NASDAQ: TERN) anunció los resultados principales de la fase 2 de 12 semanas para GLP-1RA oral TERN-601 el 21 de octubre de 2025. El ensayo mostró hasta una pérdida de peso ajustada por placebo del 4,6% a dosis >500 mg pero no alcanzó el umbral de la empresa para un GLP-1RA oral diferenciado y probablemente impide un mayor desarrollo. Los hallazgos de seguridad incluyeron principalmente eventos adversos gastrointestinales de leves a moderados (náuseas 56%, vómitos 26,9%) y tres elevaciones de enzimas hepáticas de grado 3 tras el tratamiento, dos evaluadas como relacionadas con el fármaco. Terns no avanzará con TERN-601 ni invertirá más en activos metabólicos y se centrará en TERN-701 para la CML, con datos clínicos esperados este trimestre.
Terns (NASDAQ: TERN)은 2025년 10월 21일 경구 GLP-1RA TERN-601의 12주 단계 2상 topline 결과를 발표했습니다. 임상은 용량이 >500 mg일 때 위약 대비 최대 4.6%의 체중 감소를 보여주었으나 차별화된 경구 GLP-1RA에 대한 회사의 임계치를 충족하지 못했고 향후 개발도 가능성을 차단했습니다. 안전성 결과로 주로 경증~중등도 위장관 부작용(구역 56%, 구토 26.9%)과 치료 후 3등급 간효소 상승 3건이 포함되었고, 그 중 두 건은 약물 관련으로 판정되었습니다. Terns는 TERN-601을 진행하지 않으며 대사 자산에 추가 투자도 하지 않고 CML용 TERN-701에 집중할 예정이며, 이번 분기에 임상 데이터가 기대됩니다.
Terns (NASDAQ: TERN) a annoncé les résultats initiaux de la phase 2 de 12 semaines pour l’agoniste GLP-1 oral TERN-601 le 21 octobre 2025. L’essai a montré une perte de poids ajustée par placebo allant jusqu’à 4,6% à des doses >500 mg mais n’a pas atteint le seuil de différenciation de l’entreprise pour un GLP-1RA oral et a probablement mis fin à tout développement ultérieur. Les résultats de sécurité incluent principalement des événements gastro-intestinaux bénins à modérés (nausées 56%, vomissements 26,9%) et trois élévations des enzymes hépatiques de grade 3 après traitement, dont deux jugées liées au médicament. Terns n’avancera pas avec TERN-601 ni n’investira davantage dans des actifs métaboliques et se concentrera sur TERN-701 pour la CML, avec des données cliniques attendues ce trimestre.
Terns (NASDAQ: TERN) kündigte am 21. Oktober 2025 die topline Ergebnisse der 12-wöchigen Phase-2-Studie für das orale GLP-1RA TERN-601 an. Die Studie zeigte bei Dosen >500 mg eine bis zu 4,6%-ige placeboadjustierte Gewichtsabnahme, verfehlte jedoch die Schwelle des Unternehmens für ein differenziertes orales GLP-1RA und schließt eine weitere Entwicklung wahrscheinlich aus. Sicherheitsbefunde umfassten hauptsächlich leichte bis mäßige gastrointestinale Nebenwirkungen (Übelkeit 56%, Erbrechen 26,9%) und drei Grad-3-Erhöhungen der Leberenzyme nach der Behandlung, zwei davon als medikamentenbezogen bewertet. Terns wird TERN-601 nicht vorantreiben bzw. weiter in metabolische Assets investieren und sich auf TERN-701 für CML konzentrieren, mit klinischen Daten, die in diesem Quartal erwartet werden.
تيرنز (ناسداك: TERN) أعلنت نتائج المرحلة 2 المبكرة لمدة 12 أسبوعاً لـ GLP-1RA الفموي TERN-601 في 21 أكتوبر 2025. أظهر الاختبار فقدان وزن معدل بالدواء الوهمي يصل إلى 4.6% عند الجرعات >500 ملغ، ولكنه لم يصل إلى عتبة الشركة لـ GLP-1RA فموي مميز وربما يحول دون تطويره المستقبلي. شملت نتائج السلامة في الغالب أحداثاً جانبية جهازية هضميّة خفيفة إلى معتدلة (الغثيان 56%، القيء 26.9%) و ثلاث ارتفاعات إنزيمات كبد من الدرجة 3 بعد العلاج، اثنان منها عدّتا مرتبَطتين بالدواء. لن تُواصل تيرنز TERN-601 أو تستثمر بمزيد من الأصول الأيضية، وستركز على TERN-701 لمرض التليف الكبدي المزمن CML، مع توقع صدور بيانات سريرية هذا الربع.
Terns (NASDAQ: TERN) 于 2025年10月21日宣布口服 GLP-1RA TERN-601 的12周Phase 2初步结果。试验在剂量>500 mg时显示了高达4.6%的安慰剂调整后体重减轻，但未达到公司对差异化口服GLP-1RA的门槛，可能阻止进一步开发。安全性结果主要包括轻度至中度的胃肠道不良事件（恶心56%，呕吐26.9%），以及治疗后出现的3级肝酶升高的3例，其中两例被认定与药物相关。Terns将不推进TERN-601，也不再在代谢资产上投资，而将重点放在TERN-701用于CML，临床数据预计在本季度公布。
- Placebo-adjusted weight loss up to 4.6%
- GI adverse events were mild-to-moderate; no severe GI AEs reported
- Company refocuses resources on TERN-701 CML program
- Clinical efficacy did not meet company threshold; development likely precluded
- 11.9% of participants discontinued treatment due to adverse events
- Three post-treatment grade 3 LFT elevations; two adjudicated drug-related
- Company will not advance TERN-601 or invest further in metabolic assets
Insights
Topline Phase 2 obesity results show modest efficacy and safety signals; company halts metabolic program and refocuses on oncology.
TERN-601 produced a maximum placebo-adjusted weight loss of
The main dependencies and risks are clear: the modest efficacy versus the safety signals limit clinical differentiation for an oral GLP-1RA, and the unexpected post-treatment LFT elevations create regulatory and development risk for the program. The company’s pivot concentrates resources on TERN-701, with new clinical data expected
Watch the full Phase 2 dataset publication for detailed LFT timelines and adjudication, the investigator and DILI Network assessments, and the upcoming TERN-701 Phase 1 CARDINAL readout within the stated timeframe. The most relevant short-term horizon is the forthcoming
Results show maximum placebo-adjusted weight loss of
Asymptomatic, reversible grade 3 liver enzyme elevations occurred in three participants during post-treatment follow-up period, two of which were deemed drug related
Company will not advance TERN-601 or invest in other metabolic assets
Reiterates focus on TERN-701, a potential best-in-class allosteric BCR-ABL inhibitor, for chronic myeloid leukemia with clinical data this quarter
FOSTER CITY, Calif., Oct. 21, 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 topline 12-week results from its Phase 2 trial of TERN-601, a novel, once-daily, oral GLP-1 receptor agonist (GLP-1RA) as a potential treatment for obesity.
“The threshold for a truly differentiated oral GLP-1RA therapy – one that delivers safety, tolerability and efficacy – is high. The Phase 2 topline 12-week results for TERN-601 did not meet this threshold and likely preclude further development,” said Amy Burroughs, chief executive officer of Terns. “As we’ve previously communicated, we do not plan to further invest in metabolic disease. Our team remains energized and focused on advancing our potentially best-in-class TERN-701 program in chronic myeloid leukemia (CML) with our full capabilities. We look forward to announcing new data from our Phase 1 CARDINAL trial of TERN-701 for CML this quarter.”
“We would like to thank all the trial participants, investigators, caregivers, clinical sites, and Terns team members for their support and involvement in this well-run Phase 2 trial,” said Emil Kuriakose, M.D., chief medical officer of Terns. “The results of our previous Phase 1 inpatient 28-day trial did not translate to those we observed in this 12-week trial, which was conducted in an outpatient multi-center setting. The post-treatment reversible grade 3 liver enzyme elevations were unexpected based on the lack of similar signals in preclinical and Phase 1 studies,” added Dr. Kuriakose. “We plan to publish detailed results from the Phase 2 trial in the future.”
Topline Results Summary
Baseline Characteristics
- Baseline characteristics were generally well-balanced across the treatment arms
- Participants were predominantly female (78
-79% ), mean age range was 47-53 years of age, with mean weight and body mass index (BMI) ranges of 99-102 kg and 36-37 kg/m2, respectively
Weight Loss
- Statistically significant weight loss at doses > 500 mg (up to -
4.6% placebo-adjusted)
| TERN-601 250 mg (n=27) | TERN-601 500 mg slow titration (n=28) | TERN-601 500 mg (n=28) | TERN-601 750 mg (n=28) | |
| Placebo-adj. weight loss | - | - | - | - |
| p-value | 0.056 | <0.001 | <0.0001 | <0.01 |
Safety and Tolerability
- Of the 134 participants who received TERN-601,
11.9% and8.2% discontinued treatment or had dose modification due to adverse events (AEs), respectively, the majority of which were gastrointestinal (GI) related - GI AEs were all mild or moderate, most commonly nausea (
56% ), vomiting (26.9% ), constipation (11.9% ), diarrhea (9.7% ) and appeared to be dose related - There were no severe GI AEs in any group; rates of GI AEs were overall stable over the treatment period
- Across all participants, mean AST, ALT, alkaline phosphatase, and total bilirubin remained overall stable during the treatment period. No participants had dose interruption, reduction, or discontinuation due to abnormal liver function tests (LFTs) during the treatment period
- Of three participants who had grade 3 LFT elevations during the post-treatment follow up, two participants in the 500 mg treatment arm had profiles consistent with drug induced liver injury (DILI) (one supported by findings on liver biopsy). The LFT elevations in the third participant (750 mg) had an alternate etiology of gall stones and was deemed unlikely to be drug-related by the investigator, although DILI could not be definitively ruled out. The investigator-reported assessments for all three participants agreed with the independent adjudication of the three cases by a DILI Network expert clinician
| Placebo (n=33) | TERN-601 250 mg (n=33) | TERN-601 500 mg slow titration (n=34) | TERN-601 500 mg (n=34) | TERN-601 750 mg (n=33) | TERN-601 All cohorts (n=134) | |
| Nausea | 3 ( | 16 ( | 17 ( | 22 ( | 20 ( | 75 ( |
| Vomiting | 0 | 2 ( | 10 ( | 13 ( | 11 ( | 36 ( |
| Discontinued treatment due to AE | 1 ( | 3 ( | 4 ( | 3 ( | 6 ( | 16 ( |
| Dose modification due to AE | 0 | 3 ( | 2 ( | 2 ( | 4 ( | 11 ( |
Phase 2 FALCON Trial
The FALCON Phase 2 trial is a U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of TERN-601, a novel oral GLP-1R agonist, 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
- Participants were 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
- Secondary endpoints include safety, tolerability and proportion of participants 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. For more information, please visit: www.ternspharma.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about the Company within the meaning of the federal securities laws that involve substantial risks and uncertainties. Forward-looking statements include any statements related to or in connection with the Company’s clinical development plans and activities, including the Company’s plans to not further advance development of TERN-601, to cease further investment in metabolic disease and to focus on advancing the TERN-701 program; expectations and timing of results of clinical trials and other development activities, including with respect to the FALCON and CARDINAL trials; the potential indications to be targeted by the Company with its product candidates; the therapeutic potential of the Company’s product candidates; the potential differentiation of the Company’s product candidates compared to similar or competitive products or product candidates;; the best-in-class potential of TERN-701; and the Company’s plans for and ability to continue to execute on its current development strategy. 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 industry and market trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “develop,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” 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 reports filed with the Securities and Exchange Commission, 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. New risk factors emerge from time to time and it is not possible for Company management to predict all risk factors, nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
Contacts for Terns
Investors
Kaytee Bock
investors@ternspharma.com
Media
Jenna Urban
CG Life
media@ternspharma.com
FAQ
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