MON-302 The Design of MOMENTUM: A Prospective Study of the Prevalence of Endogenous Hypercortisolism in Individuals With Resistant Hypertension

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Abstract Disclosure: J. Plutzky: Altimmune, Amgen Inc, Boehringer Ingelheim, Corcept Therapeutics, New Amsterdam, Novo Nordisk, Toku Eyes, Esperion, Novartis Pharmaceuticals. R.J. Auchus: Neurocrine Biosciences/Neurocrine UK, LTD, Spruce Biosciences, Corcept Therapeutics, Crinetics Pharmaceuticals, Recordati Rare Diseases, Adrenas Therapeutics, Mineralys Therapeutics, Quest Diagnostics, Xeris Pharmaceuticals, Novo Nordisk, H Lundbeck A/S, Sparrow Pharmaceuticals, Astellas Pharmaceuticals, Acerand Therapeutics. J.N. Basile: Eli Lilly & Company, Novo Nordisk, Recor, Medtronic, Idorsia, Mineralys, Corcept Therapeutics, Ablative Solutions. D.L. Bhatt: Corcept Therapeutics. M.J. Bloch: Recor, Amgen Inc, SoniVie, Medtronic, Esperion, Jansen Pharmaceuticals, Novartis Pharmaceuticals, Idorsia, Barologics, Corcept Therapeutics. M.A. Cavender: Amgen Inc, Boehringer Ingelheim, Cleerly, CSL Behring, Janssen Research & Development Company, Novo Nordisk, Novartis Pharmaceuticals, Silence Therapeutics, Massachusetts General Hospital/PCORI, AbbVie, Bayer, Inc., Corcept Therapeutics, Faraday Pharma, New Amsterdam Pharma. J.W. Findling: Corcept Therapeutics, Diurnal, Crinetics, Recordati. Y. Handelsman: Amgen Inc, Applied Therapeutic, Corcept Therapeutics, Ionis Pharmaceuticals Inc., Lilly USA, LLC, Merck, 89Bio, Arrowhead, AstraZeneca, Bayer, Inc., Boehringer Ingelheim, Esperion, Mankind Pharma, Merck, Merck-Pfizer, Novartis Pharmaceuticals, Novo Nordisk, Sanofi, Regeneron. S.E. Inzucchi: Boehringer Ingelheim, Lilly USA, LLC, AstraZeneca, Novo Nordisk, Merck, Pfizer, Inc., Bayer, Inc. N.E. Lepor: Amgen Inc, Arrowhead, AstraZeneca, Bayer, Inc., Esperion, Ionis Pharmaceuticals Inc., Merck, Novartis Pharmaceuticals, Novo Nordisk, Regeneron, Boehringer Ingelheim, Bristol-Myers Squibb, Corcept Therapeutics, Lexicon. N.J. Pagidipati: Alnylam, Amgen Inc, Bayer, Inc., Boehringer Ingelheim, Eli Lilly & Company, Novartis Pharmaceuticals, Novo Nordisk, Merck, Corcept Therapeutics, Coursera, Esperion, AstraZeneca, New Amsterdam, Miga Health. R.R. Townsend: Medtronic, Regeneron, AstraZeneca, BD, Orchestra Backbeat, Axio/Cytel, Novartis Pharmaceuticals, UpToDate. M.R. Weir: AstraZeneca, Novo Nordisk, Bayer, Inc., CSL Vifor, Mineralys, Vera, Corcept Therapeutics. I. Tudor: Corcept Therapeutics. D. Einhorn: Corcept Therapeutics. Hypertension affects up to 50% of US adults. Despite the availability of multiple medications, resistant hypertension (rHTN) occurs in 10-20% of cases. Endogenous hypercortisolism (eHC) may contribute to rHTN in some individuals through several mechanisms. The prevalence of eHC in individuals with rHTN in the US is currently unknown, and screening for eHC is low due to the perceived rarity and screening challenges of eHC. Recent data from CATALYST, the largest prospective study assessing eHC prevalence in individuals with difficult-to-control type 2 diabetes, reported a 40% prevalence of eHC in the subgroup of participants who also had systolic blood pressure (BP) ≥135 mm Hg despite taking ≥3 BP medications (Handelsman Y, et al. WCIRDC 2024. Poster 0050). Furthermore, CATALYST demonstrated that eHC screening could consist of a 1-mg overnight dexamethasone suppression test (DST) readily performed in clinical practice. These findings establish the need to investigate eHC prevalence in individuals with rHTN. MOMENTUM is the first large, prospective study to examine the prevalence of eHC in people with rHTN in the US. MOMENTUM is an observational study with a planned enrollment of ∼1,000 individuals aged ≥18 years with rHTN using American Heart Association criteria: A) Systolic BP above target (≥130 mm Hg) despite concurrent use of ≥3 antihypertensive medications from different classes, including a diuretic, at their maximally tolerated doses, or B) BP at <130 mm Hg or above target requiring concurrent use of ≥4 antihypertensive medications of different classes. An average of 3 automated in-office BP measurements will be taken at intervals of 2-3 minutes between readings. Key exclusion criteria are investigator-determined white coat hypertension, nonadherence to BP medications, and individuals in whom DST may be difficult to interpret, including systemic glucocorticoid exposure ≤3 months before screening, a history of an estimated glomerular filtration rate <30 mL/min/1.73 m2, severe untreated sleep apnea, or dexamethasone serum levels inadequate for suppression. eHC is defined by post-DST cortisol >1.8 µg/dL. Participants with eHC will undergo non-contrast adrenal CT scans and 8 AM adrenocorticotropic hormone and cortisol tests. Participants will be screened for primary aldosteronism and other causes of endocrine hypertension. The primary endpoint is to assess the eHC prevalence in this population. Key secondary endpoints are to assess clinical and laboratory features associated with increased eHC risk. Descriptive statistics will be used to characterize participants with and without eHC in the enrolled population. In conclusion, the MOMENTUM study, as designed and currently enrolling, will provide an estimate of eHC prevalence and its associated clinical characteristics in people with rHTN. Presentation: Monday, July 14, 2025

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