Phase 2
N=15
A Study of CIN-107 in Adults With Primary Aldosteronism
Primary Aldosteronism · Hyperaldosteronism
Bottom Line
View on ClinicalTrials.gov: NCT04605549 ↗Enrolled (actual)
15
Serious AEs
1.8%
Results posted
Mar 2026
Primary outcome: Primary: Number of Treatment Emergent Adverse Events — 27; 34; 101 Number of events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CIN-107 2 mg dosing (Drug); CIN-107 4 mg dosing (Drug); CIN-107 8 mg dosing (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Emergent Adverse Events |
27; 34; 101 | — |
| PRIMARY Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) in Patients With Primary Aldosteronism |
-24.9 | — |
| SECONDARY Change From Baseline in Mean Diastolic Blood Pressure (DBP) in Patients With Primary Aldosteronism |
-10.6 | — |
| SECONDARY The Percentage of Patients Achieving a Seated BP Response of <140/90 mmHg |
11 | — |
| SECONDARY The Percentage of Patients Achieving a Seated BP Response of <130/80 mmHg |
6 | — |
| SECONDARY The Percentage of Patients Achieving the Pharmacodynamic Marker Response |
12 | — |
Summary
This is a multicenter, open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment (Part 1), and then for eligible, consenting patients follow patients in Part 2 for up to 74 weeks for evidence of long-term safety and tolerability.
Eligibility Criteria
Inclusion Criteria
- Have been diagnosed with PA.
- Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly diagnosed with PA and have not started MRA treatment.
- Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA.
- Are willing to be compliant with the contraception and reproduction restrictions of the study.
- Have increased SBP by ≥ 20 mmHg or have SBP ≥ 160 mmHg after dosing of MRA treatment is ceased for up to 4 weeks duration, or have SBP ≥ 150 mmHg for patients who are newly diagnosed with PA and have not taken an MRA in the past 12 weeks.
Exclusion Criteria
- At Screening Visit, have a single occurrence of mean seated SBP > 180 mmHg or DBP > 110 mmHg if not taking an MRA; or have a mean seated SBP ≥ 160 mmHg or DBP ≥ 100 mmHg if currently taking an MRA.
- Have a body mass index > 45 kg/m2.
- Have had a previous surgical intervention for an adrenal adenoma or have a planned adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
- Have a documented estimated glomerular filtration rate 14 alcoholic drinks weekly.
Data sourced from ClinicalTrials.gov (NCT04605549). 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.