A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension

NCT06336356 | Completed Phase 2 Results FDA Drug

• 1 other identifier: D6970C00011
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 10

Brief Summary

The main purpose of this study is to assess the serum free cortisol response after ACTH stimulation test at baseline and at Week 8 in participants with uncontrolled hypertension.

Conditions

Uncontrolled Hypertension

Keywords

Adrenocorticotropic hormone stimulation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test

  The primary endpoint is individual participant's cortisol levels at each timepoint. Number of participants with normal stimulated serum total cortisol level at baseline are presented here. Characterisation of the serum total cortisol levels before and after ACTH stimulation test. An ACTH stimulation test using 250 μg ACTH was performed at baseline and Week 8 (End of Treatment), with serum cortisol level measured before and after ACTH stimulation test. Normal cortisol levels are defined as at least 18 μg/dL when measured 60 minutes (±10 minutes) after stimulation. If the Week 8 results show abnormal levels, a repeat test is conducted. In this repeat test, cortisol is considered abnormal only if both of the following conditions are met: the level is less than 14.8 μg/dL at 30 minutes (± 5 minutes) and less than 18 μg/dL at 60 minutes (±10 minutes).

  Week 8

Secondary Outcomes (2)

• Incidence of Abnormal Stimulated Cortisol at Week 8

  Week 8

• Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

  From Day 1 up to Week 8 or Safety follow-up (14 days post last dose), which ever comes first (up to 10 weeks)

Study Arms (2)

Arm 1: Baxdrostat 2 mg

EXPERIMENTAL

Participants will receive baxdrostat 2 mg tablet orally once daily.

Drug: Baxdrostat

Arm 2: Placebo

PLACEBO COMPARATOR

Participants will receive placebo tablet orally once daily.

Drug: Placebo

Interventions

Baxdrostat DRUG

Baxdrostat will be administered orally once daily.

Also known as: RO6836191,, CIN-107

Arm 1: Baxdrostat 2 mg

Placebo DRUG

Placebo will be administered orally once daily.

Arm 2: Placebo

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with mean seated systolic blood pressure (SBP) on automated office blood pressure measurement (AOBPM) greater than equal to (\>=) 130 millimeter of mercury (mmHg) and less than (\<) 170 mmHg at screening.
• Participants with mean seated SBP on AOBPM of \>=130 mmHg and \< 170 mmHg at randomization.
• Participants must have a stable regimen of \>=1 antihypertensive medication (at least one should be a diuretic), for at least 4 weeks prior to screening.
• Participants must have an estimated glomerular filtration rate (eGFR) \>=45 milliliter per minute (mL/min)/1.73-meter square (m\^²) at screening.
• Participants must have a serum potassium+ (K+) level \>=3.5 and \< 5.0 millimole per liter (mmol/L) at screening.

You may not qualify if:

• Mean seated diastolic blood pressure (DBP) on AOBPM \>=110 mmHg at randomization.
• Prior treatment (within the 4 weeks before screening) with angiotensin receptor Blocker (ARBs) and angiotensin converting enzyme inhibitor (ACEIs) (both taken simultaneously).
• Serum sodium (Na+) level \< 135 millimole per liter (mmol/L) at screening, determined as per central laboratory.
• New York heart association functional heart failure (HF) Class IV at screening.
• Planned percutaneous coronary intervention/coronary artery bypass grafting or percutaneous coronary intervention/coronary artery bypass grafting done within 6 months prior to screening.
• Uncontrolled diabetes with glycated haemoglobin (HbA1c) \> 10.0% (86 mmol/mol) at screening.
• Fridericia's corrected QT (QTcF) value \> 470 milliseconds (ms) at screening, unless having a pacemaker.
• Heart rate \< 45 or \> 110 beats/min in a resting position, as per vital signs assessment.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (10)

Research Site

Phoenix, Arizona, 85018, United States

Location

Research Site

Tempe, Arizona, 85281, United States

Location

Research Site

Montclair, California, 91763, United States

Location

Research Site

Tarzana, California, 91356, United States

Location

Research Site

Tampa, Florida, 33612, United States

Location

Research Site

Chicago, Illinois, 60643, United States

Location

Research Site

Metairie, Louisiana, 70006, United States

Location

Research Site

Houston, Texas, 77074, United States

Location

Research Site

Houston, Texas, 77099, United States

Location

Research Site

Norfolk, Virginia, 23502, United States

Location

Related Links

• Redacted CSP
• Redacted SAP
• Redacted CSR Synopsis

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: June 10, 2024
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (10)