Phase 2
Completed N=175
Open-Label Extension Study of Patients Previously Enrolled in Study CIN-107-124
Source: ClinicalTrials.gov NCT05459688 ↗Enrolled (actual)
175
Serious AEs
4.6%
Results posted
Dec 2024
Primary outcomePrimary: Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) — 73 Participants
Summary
This is a Phase 2, multicenter, open-label extension (OLE) study to evaluate the long-term safety, tolerability, and effectiveness of CIN-107 for up to 52 weeks in patients with HTN who have completed Part 1 or Part 2 of Study CIN-107-124. The study will be conducted at clinical sites that have participated in the double-blind, Phase 2 Study CIN-107-124.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) |
73 | — |
| PRIMARY Number of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESIs) |
7 | — |
| PRIMARY Number of Participants With Any Treatment-emergent Serious Adverse Events (TESAEs) |
8 | — |
| PRIMARY Change From Baseline in Serum Potassium |
0.08 | — |
| PRIMARY Change From Baseline in Serum Sodium |
0.6 | — |
| PRIMARY Change From Baseline in Body Weight |
-0.30 | — |
| PRIMARY Change From Baseline in Temperature |
-0.03 | — |
| PRIMARY Change From Baseline in Seated Heart Rate |
0.9 | — |
| SECONDARY Change From Baseline in Mean Seated Systolic Blood Pressure |
-5.1 | — |
| SECONDARY Change From Baseline in Mean Seated Diastolic Blood Pressure |
-3.6 | — |
| SECONDARY Achieving Mean Seated Systolic Blood Pressure <130 mmHg |
102 | — |
| SECONDARY Non-responders in Study CIN-107-124 Achieving a Seated SBP Response <130 mmHg |
20 | — |
| SECONDARY Responders in Study CIN-107-124 Achieving a Seated SBP Response <130 mmHg |
82 | — |
Eligibility Criteria
Inclusion Criteria
- Have completed Part 1 or Part 2 of Study CIN-107-124;
- Have had acceptable safety and tolerability during Study CIN-107-124 as determined by the Investigator or Medical Monitor;
- Have demonstrated ≥70% and ≤120% adherence to their single background antihypertensive agent and the CIN-107 placebo during Study CIN-107-124;
- Agree to comply with the contraception and reproduction restrictions of the study as follows:
- Male patients must agree to abstain from sperm donation from Day 1 through 90 days after the final dose of study drug;
- Female patients of childbearing potential (ie, ovulating, pre-menopausal, and not surgically sterile) must have a documented negative serum pregnancy test at enrollment (Visit 1); and
- Female patients of childbearing potential must use a highly effective method of contraception (ie, <1% failure rate) from Day 1 through 30 days after the last administration of study drug.
- Are able and willing to give informed consent for participation in the clinical study.
Exclusion Criteria
- Have met Protocol-defined stopping criteria, were withdrawn from the study, discontinued CIN-107 at the time of Visits 6 or 9, or were not compliant with the Protocol during Study CIN-107-124;
- Have received treatment with any investigational agent for disease intervention (ie, other than study drug) during Study CIN-107-124, or since the last administration of study drug in Study CIN-107-124, or plans to participate in another clinical study within 30 days of discontinuation of study drug;
- Have had any new, significant, or uncontrolled comorbidity since initially enrolling in Study CIN-107-124 that would increase the risk of the patient in Study CIN-107-130, as determined by the Investigator;
- Have had a mean seated SBP ≥170 mmHg or DBP ≥105 mmHg at the end of Part 1 or Part 2 of Study CIN-107-124;
- Have an upper arm circumference that does not meet the cuff measurement criteria for the selected BP machine at Visit 1 of Study CIN-107-130;
- Have any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the patient's participation in the study, as determined by the Investigator;
- Have experienced a de novo or reactivated serious viral infection such as hepatitis B, hepatitis C, or HIV during Study CIN-107-124;
- Have had any major episode of infection requiring hospitalization or treatment with intravenous antibiotics during Study CIN-107-124;
- Have developed a malignancy (with the exception of non-serious local and resectable basal or squamous cell carcinoma of the skin) during Study CIN-107-124;
- Have anticipated initiation of erythropoietin-stimulating agents and/or planned transfusion within 2 months after enrollment (Visit 1);
- Are expected to receive or are receiving any of the exclusionary drugs (strong cytochrome P450 3A inducers);
- Have known secondary causes of HTN (eg, renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome, or aortic coarctation) except obstructive sleep apnea;
- Have been diagnosed with New York Heart Association stage III or IV chronic heart failure during Study CIN-107-124;
- Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure during Study CIN-107-124;
- Have a known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease diagnosed from a prior echocardiogram;
- Have a planned coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) or any major surgical procedure;
- Have had a CABG or other major cardiac surgery (eg, valve replacement), peripheral arterial bypass surgery, or PCI during Study CIN-107-124;
- Have a planned dialysis
Data sourced from ClinicalTrials.gov (NCT05459688). 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. Informational only — not medical advice.