Corcept Therapeutics Initiates MOMENTUM Trial to Determine Prevalence of Hypercortisolism in Patients with Resistant Hypertension
Corcept Therapeutics (NASDAQ: CORT) has launched the MOMENTUM clinical trial to investigate the prevalence of endogenous hypercortisolism (Cushing's syndrome) in patients with resistant hypertension. The study will enroll 1,000 patients across 45 U.S. sites.
The trial follows the successful CATALYST study, which found that one in four patients with difficult-to-control type 2 diabetes has hypercortisolism, with higher prevalence in patients requiring three or more hypertension medications. Patients will be identified as having hypercortisolism if they show dexamethasone suppression test values >1.8 µg/dL and dexamethasone levels >140 ng/dL.
Led by Dr. Deepak L. Bhatt, Director of Mount Sinai Fuster Heart Hospital, the study aims to better understand treatment opportunities for resistant hypertension patients. Results are expected by year-end.
Corcept Therapeutics (NASDAQ: CORT) ha avviato il trial clinico MOMENTUM per indagare la prevalenza dell'ipercortisolismo endogeno (sindrome di Cushing) nei pazienti con ipertensione resistente. Lo studio arruolerà 1.000 pazienti in 45 siti negli Stati Uniti.
Il trial segue il successo dello studio CATALYST, che ha rilevato che uno su quattro pazienti con diabete di tipo 2 difficile da controllare presenta ipercortisolismo, con una prevalenza maggiore nei pazienti che richiedono tre o più farmaci per l'ipertensione. I pazienti saranno identificati come affetti da ipercortisolismo se mostrano valori nel test di soppressione con desametasone >1,8 µg/dL e livelli di desametasone >140 ng/dL.
Guidato dal Dr. Deepak L. Bhatt, Direttore del Mount Sinai Fuster Heart Hospital, lo studio mira a comprendere meglio le opportunità di trattamento per i pazienti con ipertensione resistente. I risultati sono attesi entro la fine dell'anno.
Corcept Therapeutics (NASDAQ: CORT) ha lanzado el ensayo clínico MOMENTUM para investigar la prevalencia del hipercortisolismo endógeno (síndrome de Cushing) en pacientes con hipertensión resistente. El estudio incluirá 1.000 pacientes en 45 sitios de EE. UU..
El ensayo sigue al exitoso estudio CATALYST, que encontró que uno de cada cuatro pacientes con diabetes tipo 2 difícil de controlar tiene hipercortisolismo, con una mayor prevalencia en pacientes que requieren tres o más medicamentos para la hipertensión. Los pacientes serán identificados como portadores de hipercortisolismo si muestran valores en la prueba de supresión con dexametasona >1.8 µg/dL y niveles de dexametasona >140 ng/dL.
Dirigido por el Dr. Deepak L. Bhatt, Director del Mount Sinai Fuster Heart Hospital, el estudio tiene como objetivo comprender mejor las oportunidades de tratamiento para los pacientes con hipertensión resistente. Se esperan resultados para fin de año.
Corcept Therapeutics (NASDAQ: CORT)는 내성 고혈압 환자에서 내인성 고코르티솔증(쿠싱 증후군)의 유병률을 조사하기 위해 MOMENTUM 임상 시험을 시작했습니다. 이 연구는 미국 내 45개 사이트에서 1,000명의 환자를 모집할 예정입니다.
이 시험은 어려운 제2형 당뇨병 환자 중 4명 중 1명이 고코르티솔증을 앓고 있다는 것을 발견한 성공적인 CATALYST 연구에 이어 진행됩니다. 고혈압 약물을 3개 이상 필요로 하는 환자에서 더 높은 유병률이 나타났습니다. 환자는 덱사메타손 억제 검사에서 >1.8 µg/dL의 값과 덱사메타손 수치 >140 ng/dL를 보일 경우 고코르티솔증으로 확인됩니다.
Mount Sinai Fuster Heart Hospital의 디팍 L. 바트 박사가 이끄는 이 연구는 내성 고혈압 환자를 위한 치료 기회를 더 잘 이해하는 것을 목표로 하고 있습니다. 결과는 연말까지 발표될 예정입니다.
Corcept Therapeutics (NASDAQ: CORT) a lancé l'essai clinique MOMENTUM pour étudier la prévalence de l'hypercortisolisme endogène (syndrome de Cushing) chez les patients souffrant d'hypertension résistante. L'étude inclura 1 000 patients dans 45 sites aux États-Unis.
L'essai fait suite à l'étude CATALYST, qui a révélé que un patient sur quatre souffrant de diabète de type 2 difficile à contrôler présente un hypercortisolisme, avec une prévalence plus élevée chez les patients nécessitant trois médicaments antihypertenseurs ou plus. Les patients seront identifiés comme ayant un hypercortisolisme s'ils montrent des valeurs au test de suppression par la dexaméthasone >1,8 µg/dL et des niveaux de dexaméthasone >140 ng/dL.
Dirigée par le Dr Deepak L. Bhatt, directeur de l'hôpital cardiaque Mount Sinai Fuster, l'étude vise à mieux comprendre les opportunités de traitement pour les patients souffrant d'hypertension résistante. Les résultats sont attendus d'ici la fin de l'année.
Corcept Therapeutics (NASDAQ: CORT) hat die MOMENTUM-Studie gestartet, um die Prävalenz von endogenem Hyperkortisolismus (Cushing-Syndrom) bei Patienten mit resistenter Hypertonie zu untersuchen. Die Studie wird 1.000 Patienten an 45 Standorten in den USA einschließen.
Die Studie folgt auf die erfolgreiche CATALYST-Studie, die ergab, dass einer von vier Patienten mit schwer kontrollierbarem Typ-2-Diabetes Hyperkortisolismus hat, wobei die Prävalenz bei Patienten, die drei oder mehr Medikamente gegen Hypertonie benötigen, höher ist. Patienten werden als hyperkortisolisch identifiziert, wenn sie Werte im Dexamethason-Suppressionstest von >1,8 µg/dL und Dexamethasonwerte von >140 ng/dL aufweisen.
Unter der Leitung von Dr. Deepak L. Bhatt, Direktor des Mount Sinai Fuster Heart Hospital, zielt die Studie darauf ab, die Behandlungsmöglichkeiten für Patienten mit resistenter Hypertonie besser zu verstehen. Ergebnisse werden bis Ende des Jahres erwartet.
- Building on successful CATALYST trial results showing 25% prevalence in diabetes patients
- Large-scale study with 1,000 patients across 45 U.S. sites
- Results expected by year-end, providing near-term catalyst
- Study is observational only, not testing treatment efficacy
- Results pending with no guaranteed positive outcome
Insights
Corcept's MOMENTUM trial represents a strategic clinical investigation that could significantly expand the company's addressable market. This 1,000-patient study aims to determine the prevalence of hypercortisolism in patients with resistant hypertension across 45 U.S. sites.
What makes this particularly interesting is that it builds directly on Corcept's previous CATALYST study, which found that
Resistant hypertension affects approximately
This is not a traditional drug efficacy trial but rather an epidemiological study designed to establish disease prevalence. The expected year-end results will serve as an important information catalyst, though any potential revenue impact would require subsequent treatment studies and regulatory approvals.
The involvement of Dr. Bhatt, a prominent cardiovascular specialist from Mount Sinai, adds credibility to this initiative. Corcept's methodical approach to market expansion through scientific investigation demonstrates a sophisticated long-term growth strategy focused on underdiagnosed endocrine disorders.
Corcept's MOMENTUM trial exemplifies a classic pharmaceutical market development strategy. Rather than simply promoting existing products, the company is conducting foundational research to potentially uncover an entirely new treatment pathway for resistant hypertension patients.
The business implications are notable. Corcept specializes in cortisol modulation therapies, with Korlym (mifepristone) already approved for Cushing's syndrome. By establishing hypercortisolism as a common underlying factor in resistant hypertension, Corcept could create diagnostic and treatment protocols that directly benefit their existing and pipeline products.
The precedent from their CATALYST trial is particularly telling - finding that
While immediate financial impact is minimal, this research represents an investment in long-term market expansion. The 1,000-patient enrollment across 45 sites indicates significant resource allocation to this strategic direction. The expected year-end results provide a near-term catalyst for information that could influence future clinical development priorities.
Investors should view this as a methodical market development initiative rather than a traditional catalyst event. Success would likely trigger follow-up treatment studies, creating a multi-year pathway toward potential market expansion in the cardiovascular space.
The MOMENTUM trial, which will enroll 1,000 patients across 45 sites in the
MOMENTUM’s design is similar to Corcept’s CATALYST clinical trial, which demonstrated that one in four patients with difficult-to-control type 2 diabetes has hypercortisolism. The trial results also showed that hypercortisolism was even more common in patients who also had cardiovascular disease, particularly in those who needed three or more medications to manage their hypertension.
“Resistant hypertension is a serious public health challenge. Patients whose hypertension remains in poor control despite receiving optimal care, including multiple medications, are at greater risk of cardiovascular morbidity and mortality,” said Deepak L. Bhatt, M.D., M.P.H., M.B.A., Director of Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai. “We hope the data from this MOMENTUM trial will expand our understanding of the challenges these patients face and open up new opportunities for treatment.” Dr. Bhatt is a lead investigator and steering committee member for MOMENTUM and a paid consultant to Corcept Therapeutics.
“The MOMENTUM trial will provide a deeper understanding of hypercortisolism as a potential underlying issue for patients with resistant hypertension,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Establishing the prevalence of hypercortisolism in this patient population will help clinicians better understand and address their patients’ needs. We expect results from this study by year-end.”
About Hypercortisolism (Cushing’s Syndrome)
Hypercortisolism is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively.
About Corcept Therapeutics
For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC’s website.
In this press release, forward-looking statements include, among others: the design, timing, results and expectations regarding our MOMENTUM trial. We disclaim any intention or duty to update forward-looking statements made in this press release.
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