vTv Therapeutics Announces FDA has Lifted Clinical Hold on Cadisegliatin Program for Diabetes
vTv Therapeutics (VTVT) announced that the FDA has lifted the clinical hold on its cadisegliatin program, including the CATT1 Phase 3 trial for type 1 diabetes (T1D). The company plans to amend the protocol to reduce the trial duration from 12 to 6 months, expediting the path to larger pivotal studies needed for NDA submission.
Cadisegliatin, an oral liver-selective glucokinase activator, aims to be the first oral adjunctive therapy to insulin for T1D. The drug has shown good tolerability in over 500 subjects with up to six months of treatment. The primary endpoint of measuring level 2 and 3 hypoglycemia rates at 6 months remains unchanged.
The clinical hold, initially placed on July 26, 2024, was due to an unresolved chromatographic signal in a human ADME study. The hold was lifted on March 14, 2025, after vTv demonstrated the signal was an experimental artifact. No patients had been dosed in the CATT1 trial during the hold period, and previous studies showed no concerning safety issues.
vTv Therapeutics (VTVT) ha annunciato che la FDA ha revocato il blocco clinico sul suo programma di cadisegliatina, inclusi gli studi CATT1 di Fase 3 per il diabete di tipo 1 (T1D). L'azienda prevede di modificare il protocollo per ridurre la durata dello studio da 12 a 6 mesi, accelerando così il percorso verso studi pivotal più ampi necessari per la presentazione della NDA.
La cadisegliatina, un attivatore della glucokinasi selettivo per il fegato da assumere per via orale, punta a diventare la prima terapia adiuvante orale all'insulina per il T1D. Il farmaco ha dimostrato una buona tollerabilità in oltre 500 soggetti con un trattamento fino a sei mesi. L'obiettivo primario di misurare i tassi di ipoglicemia di livello 2 e 3 a 6 mesi rimane invariato.
Il blocco clinico, inizialmente imposto il 26 luglio 2024, era dovuto a un segnale cromatografico irrisolto in uno studio ADME umano. Il blocco è stato revocato il 14 marzo 2025, dopo che vTv ha dimostrato che il segnale era un artefatto sperimentale. Nessun paziente era stato trattato nello studio CATT1 durante il periodo di blocco e studi precedenti non hanno mostrato problemi di sicurezza preoccupanti.
vTv Therapeutics (VTVT) anunció que la FDA ha levantado la suspensión clínica de su programa de cadisegliatina, incluyendo el ensayo CATT1 de Fase 3 para la diabetes tipo 1 (T1D). La compañía planea modificar el protocolo para reducir la duración del ensayo de 12 a 6 meses, acelerando así el camino hacia estudios pivotal más amplios necesarios para la presentación de la NDA.
La cadisegliatina, un activador de glucocinasa selectivo para el hígado, tiene como objetivo ser la primera terapia oral adyuvante a la insulina para el T1D. El fármaco ha mostrado buena tolerabilidad en más de 500 sujetos con hasta seis meses de tratamiento. El objetivo primario de medir las tasas de hipoglucemia de nivel 2 y 3 a los 6 meses permanece sin cambios.
La suspensión clínica, impuesta inicialmente el 26 de julio de 2024, se debió a una señal cromatográfica no resuelta en un estudio ADME humano. La suspensión se levantó el 14 de marzo de 2025, después de que vTv demostrara que la señal era un artefacto experimental. Ningún paciente había sido tratado en el ensayo CATT1 durante el período de suspensión, y estudios previos no mostraron problemas de seguridad preocupantes.
vTv Therapeutics (VTVT)는 FDA가 당뇨병 1형(T1D)을 위한 CATT1 3상 시험을 포함하여 cadisegliatin 프로그램에 대한 임상 보류를 해제했다고 발표했습니다. 회사는 시험 기간을 12개월에서 6개월로 단축하기 위해 프로토콜을 수정할 계획이며, 이는 NDA 제출에 필요한 더 큰 주요 연구로의 경로를 가속화합니다.
cadisegliatin은 간 선택적 경구 글루코키나제 활성제로, T1D에 대한 인슐린의 첫 번째 경구 보조 요법이 되는 것을 목표로 합니다. 이 약물은 최대 6개월 동안 500명 이상의 피험자에서 좋은 내약성을 보여주었습니다. 6개월 동안 2급 및 3급 저혈당 비율을 측정하는 주요 목표는 변경되지 않습니다.
임상 보류는 2024년 7월 26일에 처음 부과되었으며, 이는 인간 ADME 연구에서 해결되지 않은 크로마토그래픽 신호 때문이었습니다. vTv가 신호가 실험적 인공물임을 입증한 후 2025년 3월 14일에 보류가 해제되었습니다. 보류 기간 동안 CATT1 시험에서 환자가 투여되지 않았으며, 이전 연구에서는 우려되는 안전 문제를 보이지 않았습니다.
vTv Therapeutics (VTVT) a annoncé que la FDA a levé la suspension clinique de son programme de cadisegliatine, y compris l'essai CATT1 de Phase 3 pour le diabète de type 1 (T1D). L'entreprise prévoit de modifier le protocole pour réduire la durée de l'essai de 12 à 6 mois, accélérant ainsi le chemin vers des études pivot plus larges nécessaires pour la soumission de la NDA.
La cadisegliatine, un activateur de glucokinase sélectif pour le foie à prendre par voie orale, vise à être la première thérapie adjuvante orale à l'insuline pour le T1D. Le médicament a montré une bonne tolérance chez plus de 500 sujets avec un traitement allant jusqu'à six mois. L'objectif principal de mesurer les taux d'hypoglycémie de niveau 2 et 3 à 6 mois reste inchangé.
La suspension clinique, initialement imposée le 26 juillet 2024, était due à un signal chromatographique non résolu dans une étude ADME humaine. La suspension a été levée le 14 mars 2025, après que vTv a démontré que le signal était un artefact expérimental. Aucun patient n'avait été traité dans l'essai CATT1 pendant la période de suspension, et des études antérieures n'ont montré aucun problème de sécurité préoccupant.
vTv Therapeutics (VTVT) gab bekannt, dass die FDA die klinische Sperre für ihr Cadisegliatin-Programm, einschließlich der CATT1-Phase-3-Studie für Typ-1-Diabetes (T1D), aufgehoben hat. Das Unternehmen plant, das Protokoll zu ändern, um die Studiendauer von 12 auf 6 Monate zu verkürzen und somit den Weg zu größeren entscheidenden Studien zu beschleunigen, die für die NDA-Einreichung erforderlich sind.
Cadisegliatin, ein oral verabreichter, leberspezifischer Glukokinase-Aktivator, soll die erste orale Zusatztherapie zur Insulinbehandlung für T1D werden. Das Medikament hat in über 500 Probanden eine gute Verträglichkeit bei einer Behandlungsdauer von bis zu sechs Monaten gezeigt. Der primäre Endpunkt zur Messung der Raten von Hypoglykämie der Stufen 2 und 3 nach 6 Monaten bleibt unverändert.
Die klinische Sperre, die ursprünglich am 26. Juli 2024 verhängt wurde, war auf ein ungelöstes chromatographisches Signal in einer humanen ADME-Studie zurückzuführen. Die Sperre wurde am 14. März 2025 aufgehoben, nachdem vTv nachgewiesen hatte, dass das Signal ein experimentelles Artefakt war. Während der Sperrzeit wurden keine Patienten in der CATT1-Studie behandelt, und frühere Studien zeigten keine besorgniserregenden Sicherheitsprobleme.
- FDA lifted clinical hold on cadisegliatin program
- Trial duration reduction from 12 to 6 months accelerates path to NDA submission
- Potential first-in-class oral adjunctive therapy for type 1 diabetes
- Strong safety profile with 500+ subjects treated
- Previous clinical hold delayed development timeline
- Protocol amendment required for trial continuation
Insights
The FDA's decision to lift the clinical hold on vTv Therapeutics' cadisegliatin program represents a significant regulatory milestone for the company. This resolution removes a major development obstacle for their lead asset in type 1 diabetes, a therapy positioned as potentially the first oral adjunct to insulin.
The nature of the clinical hold is particularly noteworthy - it stemmed from a technical issue (chromatographic signal) that was ultimately determined to be an experimental artifact rather than a safety concern. This technical resolution, rather than a fundamental issue with the drug candidate itself, preserves the integrity of cadisegliatin's overall safety profile, which the company reports has been generally well-tolerated in over 500 subjects.
The company's decision to amend the protocol to shorten the trial from 12 to 6 months represents a strategic acceleration of their clinical development timeline. By maintaining the same primary endpoint while eliminating the extended safety monitoring period, vTv can potentially expedite the path to their subsequent pivotal studies and eventual NDA submission.
For a company with vTv's market capitalization (
Cadisegliatin's development as a liver-selective glucokinase activator represents a mechanistically differentiated approach to type 1 diabetes management. The potential to become the first oral adjunctive therapy to insulin for T1D would address a significant unmet need in diabetes care, where treatment options beyond insulin remain
The CATT1 trial's focus on measuring level 2 and 3 hypoglycemia rates as the primary endpoint is clinically meaningful. Hypoglycemia remains one of the most concerning and potentially dangerous complications of insulin therapy. An adjunctive therapy that could improve glycemic control while reducing hypoglycemia risk would provide substantial clinical value.
The compound's oral administration route offers a significant practical advantage over injectable adjunctive therapies. For T1D patients already managing daily insulin injections, an oral option could improve treatment adherence and quality of life.
While the protocol amendment reduces the overall safety data collection period, the existing safety database of over 500 subjects with up to six months of treatment provides reasonable preliminary confidence. The fact that no patients had been dosed in the CATT1 trial before the hold indicates minimal setbacks to patient recruitment and data collection timelines. The regulatory pathway now appears clear for this potentially important addition to the T1D treatment armamentarium.
Cadisegliatin has the potential to be the first oral adjunct therapy for type 1 diabetes
CATT1 Phase 3 trial expected to resume following submission of protocol amendment shortening the overall duration of the trial from 12 to 6 months
HIGH POINT, N.C., March 17, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes (T1D), today announced that the United States Food and Drug Administration (FDA) has lifted the clinical hold on the cadisegliatin clinical program, which includes the CATT1 Phase 3 trial in type 1 diabetes (T1D). Cadisegliatin is an oral, liver-selective glucokinase activator that has been generally well tolerated in over 500 subjects to date with up to six months of treatment.
vTv Therapeutics expects to resume the trial following submission of a protocol amendment to reduce the overall duration of the CATT1 trial from 12 months to 6 months, which will help to expedite the initiation of required larger pivotal studies for future New Drug Application (NDA) submission. The original primary endpoint of ascertaining level 2 and 3 hypoglycemia rates at 6 months will not change. The planned amendment will not include the additional 6-month period to collect safety data. By shortening the trial from 12 to 6 months, the Company will be able to obtain topline data from the study more quickly.
“We are pleased that the FDA has lifted the clinical hold on our cadisegliatin program and are eager to resume our Phase 3 trial. Importantly, we plan to submit a protocol amendment to reduce the time to topline data by 6-months, which will allow us to initiate our larger Phase 3 studies sooner to support our future NDA submission,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. “Cadisegliatin has the potential to be the first oral adjunctive therapy to insulin for T1D and we look forward to further evaluating the effects of cadisegliatin on glycemic control and incidence of hypoglycemia over insulin alone after reinitiating the CATT1 Phase 3 trial.”
On July 26, 2024, vTv Therapeutics announced a clinical hold on the CATT1 Phase 3 trial based on the discovery of a chromatographic signal in a human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy. No patient had been dosed in the CATT1 trial at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues. The clinical hold was lifted as of March 14, 2025, following submission of a complete response letter by vTv Therapeutics which concluded that the chromatographic signal was an experimental artifact.
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 to insulin for type 1 diabetes (T1D). In nonclinical 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 Inc. is a late stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates intended to help treat millions with chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes.
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FAQ
What caused the FDA clinical hold on VTVT's cadisegliatin program and when was it lifted?
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