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A Study of CIN-107 in Patients With Uncontrolled Hypertension
Phase 2 trial testing CIN-107 in Uncontrolled Hypertension in 249 participants. Completed in 10 October 2022.
| Lead sponsor | CinCor Pharma, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 249 |
| Start date | 7 December 2021 |
| Primary completion | 13 September 2022 |
| Estimated completion | 10 October 2022 |
| Sites | 63 locations across United States |
CinCor Pharma, Inc.
18 and older, any sex, with Uncontrolled Hypertension. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary efficacy endpoint was the change from baseline in mean seated SBP after 8 weeks of treatment in patients with uncontrolled HTN (Part 1).
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -16.6 | ± 1.58 |
| CIN-107 0.5 mg | -17.0 | ± 1.63 |
| CIN-107 1 mg | -16.0 | ± 1.62 |
| CIN-107 2 mg | -19.8 | ± 1.67 |
The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -5.9 | ± 1.17 |
| CIN-107 0.5 mg | -5.8 | ± 1.20 |
| CIN-107 1 mg | -5.0 | ± 1.19 |
| CIN-107 2 mg | -5.4 | ± 1.23 |
The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -19.90 | ± 29.183 |
| CIN-107 0.5 mg | -114.16 | ± 31.305 |
| CIN-107 1 mg | -140.45 | ± 29.999 |
| CIN-107 2 mg | -121.64 | ± 30.760 |
The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.70 | ± 0.490 |
| CIN-107 0.5 mg | -2.76 | ± 0.493 |
| CIN-107 1 mg | -2.95 | ± 0.508 |
| CIN-107 2 mg | -2.92 | ± 0.515 |
The percentage of patients achieving a mean seated SBP \<130 mmHg ("responders") with CIN-107 compared to placebo after 8 weeks of treatment (Part 1; Weeks 1 to 8)
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 36 | |
| CIN-107 0.5 mg | 36 | |
| CIN-107 1 mg | 33 | |
| CIN-107 2 mg | 43 |
The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -20.08 | ± 16.584 |
| CIN-107 0.5 mg | -6.54 | ± 15.739 |
| CIN-107 1 mg | -5.74 | ± 10.703 |
| CIN-107 2 mg | 4.11 | ± 17.930 |
The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 92.902 | ± 144.3969 |
| CIN-107 0.5 mg | 63.565 | ± 195.0495 |
| CIN-107 1 mg | 88.041 | ± 91.2996 |
| CIN-107 2 mg | -140.961 | ± 151.5431 |
Time frame: Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | CIN-107 0.5 mg | CIN-107 1 mg | CIN-107 2 mg | Part II - CIN-107 2 mg |
|---|---|---|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — |
| Hypertensive urgency | Vascular disorders | — | — | — | — | — |
| Bradycardia | Cardiac disorders | — | — | — | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — | — | — | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Reaction | System | Placebo | CIN-107 0.5 mg | CIN-107 1 mg | CIN-107 2 mg | Part II - CIN-107 2 mg |
|---|---|---|---|---|---|---|
| Hyperkalaemia | Metabolism and nutrition disorders | — | — | — | — | — |
| SARS-CoV-2 test positive | Investigations | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — |
Most-reported serious reactions: Hyperglycaemia, Dizziness, Hypertensive urgency, Bradycardia, Acute myocardial infarction, Acute respiratory failure.
Data from ClinicalTrials.gov NCT05137002 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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