Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1

Inclusion criteria

• . Participants must have a documented pathogenic or likely pathogenic activating variant, or variant of uncertain significance, of the calcium sensing receptor (CASR) gene associated with biochemical findings of hypoparathyroidism.
• . Participants must have a documented history of symptoms or signs of ADH1.
• . Participants 16 to \<18 years old must have closed growth plates on hand radiograph.
• . Participants treated with thiazide diuretics must discontinue thiazides for at least 14 days prior to SoC Optimization Visit 1 through Week 24 (Period 3). When the thiazide is being used as an antihypertensive, alternative therapy will be prescribed by the Investigator as needed.
• . Participants treated with phosphate binders (other than calcium salts) must discontinue the phosphate binders at least one day prior to the SoC Optimization Visit 1.
• . Participants treated with magnesium or potassium supplements must be willing to discontinue such treatment prior to the first dose of encaleret.
• . Participants treated with potassium-sparing diuretics must be willing to discontinue such treatment prior to the first dose of encaleret.
• . Participants must meet SoC Optimization criteria as defined in the protocol.

Exclusion criteria