Phase 2
N=249
A Study of CIN-107 in Patients With Uncontrolled Hypertension
Uncontrolled Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT05137002 ↗Enrolled (actual)
249
Serious AEs
1.1%
Results posted
Aug 2023
Primary outcome: Primary: Change From Baseline in Mean Seated Systolic BP (SBP) — -16.6; -17.0; -16.0; -19.8 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CIN-107 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CinCor Pharma, Inc.
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Seated Systolic BP (SBP) |
-16.6; -17.0; -16.0; -19.8 | — |
| SECONDARY Change From Baseline in Mean Seated Diastolic BP (DBP) |
-5.9; -5.8; -5.0; -5.4 | — |
| SECONDARY Change From Baseline in 24-hour Urine Aldosterone |
-19.90; -114.16; -140.45; -121.64 | — |
| SECONDARY Change From Baseline in 24-hour Serum Aldosterone |
-0.70; -2.76; -2.95; -2.92 | — |
| SECONDARY Percentage of Patients Achieving a Mean Seated SBP <130 mmHg |
36; 36; 33; 43 | — |
| SECONDARY Change From Baseline in 24-hour Urine Renin |
-20.08; -6.54; -5.74; 4.11 | — |
| SECONDARY Change From Baseline in 24-hour Serum Renin |
92.902; 63.565; 88.041; -140.961 | — |
Summary
This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of baxdrostat (also called CIN-107) in the treatment of patients with uncontrolled hypertension. The primary objective was to demonstrate that treatment with baxdrostat for 8 weeks would lower the systolic blood pressure (SBP) in patients who were hypertensive despite taking one or two anti-hypertensive medications.
Participants were assigned to take placebo or baxdrostat once per day for 8 weeks while they continued taking the regular anti-hypertensive medications. At the end of the 8-week period, qualified patients could participate in Part II of the study and receive 2 mg baxdrostat for 4 weeks while they discontinued taking the background anti-hypertensive medication.
Eligibility Criteria
Inclusion Criteria
- Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
- Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;
- Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period
- If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and
- Agrees to comply with the contraception and reproduction restrictions of the study;
Exclusion Criteria
- Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;
- Has a body mass index (BMI) >50 kg/m2;
- Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);
- Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;
- Has documented estimated eGFR 10% at Screening;
- Has planned dialysis or kidney transplantation planned during the course of the study;
- Prior solid organ transplant and/or cell transplants;
- Sodium 5 mEq/L;
- White blood cell count >15 × E9/L or absolute neutrophil count <1 × E9/L at Screening;
- Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
- Has typical consumption of ≥14 alcoholic drinks weekly;
Data sourced from ClinicalTrials.gov (NCT05137002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.