vTv Therapeutics Announces First Study Participant Randomized in CATT1 Phase 3 Trial of Cadisegliatin in Type 1 Diabetes
vTv Therapeutics (Nasdaq: VTVT) has announced the randomization of its first participant in the CATT1 Phase 3 trial for cadisegliatin, a potential first-in-class oral treatment for Type 1 Diabetes (T1D). The trial will evaluate cadisegliatin as an adjunctive treatment to insulin in adults with T1D.
The study will enroll approximately 150 participants across 25 U.S. sites, testing two dose regimens (800 mg once or twice daily) against placebo. The drug, which has received FDA Breakthrough Therapy designation, has shown good tolerability in over 500 subjects. The trial's primary endpoint focuses on hypoglycemic events, with topline results expected in second half of 2026.
vTv Therapeutics (Nasdaq: VTVT) ha annunciato la randomizzazione del primo partecipante nello studio di fase 3 CATT1 per cadisegliatin, un potenziale trattamento orale di nuova classe per il diabete di tipo 1 (T1D). Lo studio valuterà cadisegliatin come trattamento aggiuntivo all'insulina negli adulti con T1D.
Lo studio arruolerà circa 150 partecipanti in 25 centri negli Stati Uniti, testando due regimi di dosaggio (800 mg una o due volte al giorno) rispetto al placebo. Il farmaco, che ha ricevuto la designazione di terapia rivoluzionaria dalla FDA, ha dimostrato buona tollerabilità in oltre 500 soggetti. L'endpoint primario dello studio si concentra sugli eventi ipoglicemici, con i risultati principali attesi nella seconda metà del 2026.
vTv Therapeutics (Nasdaq: VTVT) ha anunciado la aleatorización de su primer participante en el ensayo de fase 3 CATT1 para cadisegliatin, un posible tratamiento oral innovador para la diabetes tipo 1 (T1D). El ensayo evaluará cadisegliatin como tratamiento complementario a la insulina en adultos con T1D.
El estudio inscribirá aproximadamente a 150 participantes en 25 sitios de EE. UU., probando dos regímenes de dosis (800 mg una o dos veces al día) frente a placebo. El medicamento, que ha recibido la designación de terapia innovadora de la FDA, ha mostrado buena tolerabilidad en más de 500 sujetos. El objetivo principal del ensayo se centra en los eventos de hipoglucemia, con resultados preliminares esperados en la segunda mitad de 2026.
vTv Therapeutics (나스닥: VTVT)는 제1형 당뇨병(T1D)을 위한 최초의 경구 치료제 후보인 카디세글리틴의 CATT1 3상 시험에 첫 참가자를 무작위 배정했다고 발표했습니다. 이 시험은 성인 T1D 환자에서 인슐린 보조 치료제로서 카디세글리틴을 평가할 예정입니다.
이 연구는 미국 내 25개 기관에서 약 150명의 참가자를 모집하며, 800mg을 하루 한 번 또는 두 번 투여하는 두 가지 용량 요법과 위약을 비교합니다. FDA로부터 혁신 치료제 지정을 받은 이 약물은 500명 이상의 피험자에게서 우수한 내약성을 보였습니다. 시험의 주요 평가 변수는 저혈당 사건이며, 2026년 하반기에 주요 결과가 발표될 예정입니다.
vTv Therapeutics (Nasdaq : VTVT) a annoncé la randomisation de son premier participant dans l'essai de phase 3 CATT1 pour le cadisegliatin, un traitement oral potentiel de nouvelle classe pour le diabète de type 1 (DT1). L'essai évaluera le cadisegliatin en traitement adjuvant à l'insuline chez les adultes atteints de DT1.
L'étude recrutera environ 150 participants répartis sur 25 sites aux États-Unis, testant deux schémas posologiques (800 mg une ou deux fois par jour) contre placebo. Le médicament, qui a reçu la désignation de thérapie révolutionnaire par la FDA, a montré une bonne tolérance chez plus de 500 sujets. Le critère principal de l'essai porte sur les événements hypoglycémiques, avec des résultats principaux attendus dans la deuxième moitié de 2026.
vTv Therapeutics (Nasdaq: VTVT) hat die Randomisierung des ersten Teilnehmers in der CATT1 Phase-3-Studie für Cadisegliatin bekannt gegeben, einer potenziellen neuartigen oralen Behandlung für Typ-1-Diabetes (T1D). Die Studie wird Cadisegliatin als Zusatztherapie zu Insulin bei Erwachsenen mit T1D evaluieren.
Die Studie wird etwa 150 Teilnehmer an 25 Standorten in den USA einschließen und zwei Dosierungsschemata (800 mg einmal oder zweimal täglich) gegen Placebo testen. Das Medikament, das die FDA Breakthrough Therapy Designation erhalten hat, zeigte gute Verträglichkeit bei über 500 Probanden. Der primäre Endpunkt der Studie fokussiert auf hypoglykämische Ereignisse, mit den ersten Ergebnissen erwartet in der zweiten Hälfte 2026.
- Received FDA Breakthrough Therapy designation for cadisegliatin
- Well-tolerated in over 500 subjects with up to six months of treatment
- Addresses significant unmet need as potentially first FDA-approved oral adjunct therapy to insulin for T1D
- Targets large market of 1.6 million Americans living with T1D
- Extended timeline with topline results not expected until second half of 2026
- Requires relatively large Phase 3 trial across 25 sites
Insights
vTv's advancement of cadisegliatin to Phase 3 trials marks a significant milestone for a potential first oral adjunct therapy for Type 1 diabetes.
vTv Therapeutics has reached a critical milestone with the randomization of the first participant in their Phase 3 CATT1 trial for cadisegliatin. This liver-selective glucokinase activator represents a potential first-in-class oral therapy for Type 1 diabetes (T1D), an area with significant unmet need despite advances in glucose monitoring devices.
The FDA's Breakthrough Therapy designation for cadisegliatin underscores its promising clinical profile. The compound has demonstrated favorable tolerability in over 500 subjects with treatment durations up to six months. What makes this development particularly noteworthy is that there is currently no FDA-approved oral adjunct therapy to insulin for T1D management.
The Phase 3 CATT1 trial design is robust: randomized, double-blind, and placebo-controlled with approximately 150 participants across up to 25 U.S. sites. The study will evaluate two dosing regimens (800 mg once or twice daily) over a six-month treatment period. The primary endpoint focuses on hypoglycemic events, while secondary endpoints include HbA1c reduction, time in target glycemic range, and incidence of diabetic ketoacidosis.
Significantly, the mechanism of glucokinase activation shows potential to improve glycemic control while possibly reducing risks of both hypoglycemia and ketosis - addressing the fundamental "tightrope" challenge in T1D management. Topline results expected in H2 2026 will be crucial in determining whether cadisegliatin can deliver on its promise to transform T1D care for the 1.6 million Americans living with this condition.
Topline results from CATT1 Phase 3 trial expected in second half of 2026
HIGH POINT, N.C., Aug. 07, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced the first study participant has been randomized in the Company’s CATT1 Phase 3 trial investigating cadisegliatin as an adjunctive treatment to insulin in adults with type 1 diabetes (T1D). Cadisegliatin is a potential first-in-class, oral, liver-selective glucokinase activator for T1D that has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) and has been well-tolerated in over 500 subjects to date with up to six months of treatment.
Despite major advances made in medical devices used to help manage blood glucose levels in people living with T1D, there have been few therapeutic advances. To date, there has not been any FDA-approved oral adjunct therapy to insulin to treat T1D. “Randomizing the first participant in CATT1 represents another key milestone for vTv’s development of cadisegliatin as a potential therapy to improve glycemic control for the nearly 1.6 million Americans living with T1D,” said Dr. Thomas Strack, Chief Medical Officer of vTv Therapeutics. “We look forward to reporting topline Phase 3 data from CATT1 in the second half of 2026.”
The Phase 3 CATT1 trial (NCT06334133) is being conducted at up to 25 sites in the U.S. Recruitment is ongoing, and the trial is expected to enroll approximately 150 participants. The trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of cadisegliatin over six months in adults 18 years or older diagnosed with T1D. Two different dose regimens (800 mg once or twice daily) of orally administered cadisegliatin versus placebo will be assessed in participants currently being treated with multiple daily insulin injections or continuous subcutaneous insulin infusion. Per the protocol, continuous glucose monitors (CGM) will now be provided to all participants to inform the primary study endpoint, which is the incidence of level 2 and 3 hypoglycemic events in cadisegliatin-treated participants compared to those in the placebo group (insulin alone). Select secondary endpoints include reduction in hemoglobin A1C (HbA1c), time in target range of glycemic control, and incidence of diabetic ketoacidosis.
“Although there have been major advances in medical devices for the treatment of type 1 diabetes, there is a huge unmet need to identify therapies that improve glycemia without increasing the risk of ketosis or hypoglycemia,” said diabetes expert, Klara Klein, MD, PhD, who is Assistant Professor of Medicine at the University of North Carolina at Chapel Hill. “People with type 1 diabetes continue to walk a tightrope between hyper- and hypoglycemia. There's real potential for glucokinase activators not only to improve glycemia overall but to do so while providing some protection against hypoglycemia and, potentially, diabetic ketoacidosis, which could ease some of the mental burden of type 1 diabetes care.”
About Cadisegliatin
Cadisegliatin (TTP399) is a novel, oral small molecule, liver-selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment for type 1 diabetes (T1D). In non-clinical studies, cadisegliatin, acting selectively on the liver, increased the activity of glucokinase independently from insulin which supports clinical investigation of improvement in glycemic control through hepatic glucose uptake and glycogen storage.
Cadisegliatin is under investigation and the safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated.
About vTv Therapeutics
vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates intended to help treat people living with diabetes and other chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, currently in a Phase 3 trial, a potential first-in-class oral glucokinase activator being investigated for the treatment of type 1 diabetes. vTv and its development partners are investigating multiple molecules across different indications for chronic diseases. Learn more at vtvtherapeutics.com or follow the company on LinkedIn or X.
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FAQ
What is the primary endpoint of vTv Therapeutics' CATT1 Phase 3 trial for cadisegliatin?
How many participants will be enrolled in VTVT's CATT1 Phase 3 trial?
What dosing regimens are being tested in the CATT1 Phase 3 trial?
When will vTv Therapeutics (VTVT) report topline results from the CATT1 trial?
What makes cadisegliatin unique in the Type 1 Diabetes treatment landscape?
