Uncontrolled HypertensionPhase 2HALONCT05137002

A Study of CIN-107 in Patients With Uncontrolled Hypertension

A Phase 2 study testing CIN-107 in people with Uncontrolled Hypertension, run by CinCor Pharma, Inc. at 63 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Uncontrolled Hypertension
What is being tested?: CIN-107
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 249 participants
Where: 63 sitesUnited States
Study dates: 7 Dec 2021to 10 Oct 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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 <30 mL/min/1.73m2;
Has known and documented New York Heart Association stage III or IV chronic heart failure;

Show all 18Show fewer

Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
Major cardiac surgery within 6 months before Screening;
Has chronic permanent atrial fibrillation;
Has uncontrolled diabetes with glycated hemoglobin >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 <130 mEq/L;
Potassium <3.5 mEq/L;
Potassium >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;

Trial locations and contacts

63 sites in 1 country.

City, postcode or hospital

63 sites in 1 country

United States63 sites

CinCor Site 33
Addison, Illinois, 60101
CinCor Site 48
Austin, Texas, 78705
CinCor Site 11
Brooklyn, New York, 11201
CinCor Site 72
Brownsburg, Indiana, 46112
CinCor Site 14
Buford, Georgia, 30519
CinCor Site 32
Carrollton, Texas, 75006
CinCor Site 60
Chattanooga, Tennessee, 37401
CinCor Site 40
Chicago, Illinois, 60607
CinCor Site 15
Cincinnati, Ohio, 45221
CinCor Site 18
Clearwater, Florida, 33765
CinCor Site 24
Columbus, Ohio, 43213
CinCor Site 41
Cooper City, Florida, 33024
CinCor Site 68
Dallas, Texas, 75234
CinCor Site 4
Dayton, Ohio, 45377
CinCor Site 57
Denver, Colorado, 80209
CinCor Site 38
Elkridge, Maryland, 21043
CinCor Site 38
Elkridge, Maryland, 21075
CinCor Site 69
Encinitas, California, 92024
CinCor Site 61
Georgetown, Texas, 78613
CinCor Site 42
Gurnee, Illinois, 60031
CinCor Site 28
Homestead, Florida, 33166
CinCor Site 55
Houston, Texas, 77036
CinCor Site 3
Houston, Texas, 77040
CinCor Site 9
Jupiter, Florida, 33458
CinCor Site 58
Katy, Texas, 77450
CinCor Site 1
Lake Worth, Florida, 33460
CinCor Site 62
Lampasas, Texas, 76550
CinCor Site 7
Lexington, Kentucky, 40503
CinCor Site 6
Lincoln, California, 95648
CinCor Site 20
Los Angeles, California, 90057
CinCor Site 21
Louisville, Kentucky, 40213
CinCor Site 70
Lynwood, California, 90262
CinCor Site 2
Manassas, Virginia, 20108
CinCor Site 30
Marrero, Louisiana, 70072
CinCor Site 26
McAllen, Texas, 78501
CinCor Site 59
Metairie, Louisiana, 70004
CinCor Site 12
Miami, Florida, 33032
CinCor Site 54
Miami, Florida, 33106
CinCor Site 13
Miami, Florida, 33155
CinCor Site 17
Miami, Florida, 33183
CinCor Site 50
Morton, Illinois, 61550
CinCor Site 19
New Orleans, Louisiana, 70112
CinCor Site 5
Norfolk, Virginia, 23510
CinCor Site 36
Northridge, California, 91324
CinCor Site 29
Oceanside, California, 92049
CinCor Site 43
Oklahoma City, Oklahoma, 73119
CinCor Site 64
Olive Branch, Mississippi, 38654
CinCor Site 46
Panorama City, California, 91402
CinCor Site 45
Salt Lake City, Utah, 84102
CinCor Site 53
San Antonio, Texas, 78209
CinCor Site 47
San Dimas, California, 91773
CinCor Site 49
Santa Ana, California, 92705
CinCor Site 27
Saraland, Alabama, 36571
CinCor Site 25
Shreveport, Louisiana, 71106
CinCor Site 65
Staten Island, New York, 10305
CinCor Site 10
Sugar Land, Texas, 77479
CinCor Site 16
Tampa, Florida, 33606
CinCor Site 22
Troy, Michigan, 48085
CinCor Site 35
Tucson, Arizona, 85712
CinCor Site 31
Waterbury, Connecticut, 06708
CinCor Site 63
West Des Moines, Iowa, 50266
CinCor Site 52
West Hills, California, 91307
CinCor Site 34
Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 8 Weeks of Treatment in Patients With Uncontrolled Hypertension

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.

Conditions: Uncontrolled Hypertension
Being tested: CIN-107, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CIN-107Drug
Also called Baxdrostat
CIN-107 tablets by mouth once daily
PlaceboDrug
Placebo tablets by mouth once daily

Study groups in NCT05137002
Study group	Role	What they receive
CIN-107 0.5 mg	Experimental	Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks Receives: Drug: CIN-107
CIN-107 1 mg	Experimental	Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks Receives: Drug: CIN-107
CIN-107 2 mg	Experimental	Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control Receives: Drug: CIN-107
Placebo	Placebo comparator	Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mean Seated Systolic BP (SBP)
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).
Measured: 8 weeks

Secondary outcomes (6)

Change From Baseline in Mean Seated Diastolic BP (DBP)
The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
Measured: 8 weeks
Change From Baseline in 24-hour Urine Aldosterone
The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)
Measured: 8 weeks
Change From Baseline in 24-hour Serum Aldosterone
The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)
Measured: 8 weeks
Percentage of Patients Achieving a Mean Seated SBP <130 mmHg
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)
Measured: 8 weeks
Change From Baseline in 24-hour Urine Renin
The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
Measured: 8 weeks
Change From Baseline in 24-hour Serum Renin
The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 202110 Oct 2022

First posted30 Nov 2021
Study start7 Dec 2021
Primary completion13 Sep 2022
Study completion10 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 249 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05137002
Sponsor's protocol ID: CIN-107-124
Acronym: HALO
Status last verified: Jul 2023
First submitted: 16 Nov 2021
Last updated: 1 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Hypertension
Not yet recruitingPhase 2
A Study Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
Uncontrolled Hypertension, Resistant Hypertension
RecruitingPhase 2
A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
Uncontrolled Hypertension
Recruiting
Effectiveness and Cost-Effectiveness of a Digital Care Pathway and Asynchronous Communication for Patients With Hypertension
Hypertension
RecruitingPhase 2/3
A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.
Uncontrolled or Resistant Hypertension

All Uncontrolled Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 8 Weeks of Treatment in Patients With Uncontrolled Hypertension
ClinicalTrials.gov ID: NCT05137002
Acronym / sponsor ID: HALO / CIN-107-124
Conditions: Uncontrolled Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 249 participants (actual)
Lead sponsor: CinCor Pharma, Inc.Industry (pharma, biotech, devices)
Study start: 7 Dec 2021 (actual)
Primary completion: 13 Sep 2022 (actual)
Study completion: 10 Oct 2022 (actual)
First posted: 30 Nov 2021 (actual)
Results: Posted 1 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
CIN-107 0.5 mg	Experimental	Drug: CIN-107Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks
CIN-107 1 mg	Experimental	Drug: CIN-107Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks
CIN-107 2 mg	Experimental	Drug: CIN-107Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control
Placebo	Placebo comparator	Drug: PlaceboRemain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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;

Key exclusion criteria (18 listed)

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 <30 mL/min/1.73m2;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CIN-107Also: BaxdrostatCIN-107 tablets by mouth once daily	Drug	CIN-107 0.5 mg, CIN-107 1 mg, CIN-107 2 mg
PlaceboPlacebo tablets by mouth once daily	Drug	Placebo

Primary outcome

Change From Baseline in Mean Seated Systolic BP (SBP)
Time frame: 8 weeks
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).

6 secondary outcomes

Change From Baseline in Mean Seated Diastolic BP (DBP)
Time frame: 8 weeks
Change From Baseline in 24-hour Urine Aldosterone
Time frame: 8 weeks
Change From Baseline in 24-hour Serum Aldosterone
Time frame: 8 weeks
Percentage of Patients Achieving a Mean Seated SBP <130 mmHg
Time frame: 8 weeks
Change From Baseline in 24-hour Urine Renin
Time frame: 8 weeks
Change From Baseline in 24-hour Serum Renin
Time frame: 8 weeks

Results and safety

Results posted to the registry on 1 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	64	60
CIN-107 0.5 mg	63	55
CIN-107 1 mg	62	58
CIN-107 2 mg	60	54
Part II - CIN-107 2mg	0	0

Primary outcome: Change From Baseline in Mean Seated Systolic BP (SBP)

Time frame: 8 weeks. Least squares mean (Standard Error). Unit: mmHg

Measure	Placebo n = 61	CIN-107 0.5 mg n = 57	CIN-107 1 mg n = 58	CIN-107 2 mg n = 55
Value	-16.6 (1.58)	-17.0 (1.63)	-16.0 (1.62)	-19.8 (1.67)

Population analysed: mITT Population - Four subjects (1, 2, 1 subjects from Placebo, 0.5mg CIN 107, and 2mg CIN 107, respectively) discontinued Part 1 early, but had their early termination (ET) visits within Week 8/Visit 6 analysis visit window.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 64 (0%)	5 of 64 (7.8%)	0 of 64
CIN-107 0.5 mg	0 of 63 (0%)	8 of 63 (12.7%)	0 of 63
CIN-107 1 mg	1 of 62 (1.6%)	6 of 62 (9.7%)	0 of 62
CIN-107 2 mg	1 of 60 (1.7%)	3 of 60 (5%)	1 of 60
Part II - CIN-107 2 mg	3 of 213 (1.4%)	6 of 213 (2.8%)	0 of 213

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Uncontrolled Hypertension

Active, not recruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Hypertension
Not yet recruitingPhase 2
A Study Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
Uncontrolled Hypertension, Resistant Hypertension
RecruitingPhase 2
A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
Uncontrolled Hypertension
Recruiting
Effectiveness and Cost-Effectiveness of a Digital Care Pathway and Asynchronous Communication for Patients With Hypertension
Hypertension
RecruitingPhase 2/3
A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.
Uncontrolled or Resistant Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

63 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CIN-107 in people with Uncontrolled Hypertension, run by CinCor Pharma, Inc. at 63 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Seated Systolic BP (SBP) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05137002.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.