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> Web page: https://trialight.com/data/trial/a-study-of-cin-107-in-patients-with-uncontrolled-29eace52-bbee-404c-a1e4-9a73803a86f9
> Record changed: 2026-11-04

# A Study of CIN-107 in Patients With Uncontrolled Hypertension

NCT05137002

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

Phase

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

Participants

249

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

Lead sponsor

CinCor Pharma, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

Start date

2021-12-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

Number of sites

63

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

## Title and summary

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Acronym**

HALO

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Short title**

A Study of CIN-107 in Patients With Uncontrolled Hypertension

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Registry reports results**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Phase**

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

## Dates

**Completion date**

2022-10-10

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**First posted**

2021-11-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Registry last updated**

2023-08-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Primary completion date**

2022-09-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Start date**

2021-12-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

## Size and sites

**Actual participants**

249

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Participants**

249

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Protocol amendments**

5

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Number of sites**

63

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Lead sponsor**

CinCor Pharma, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

## Identifiers

**Registry ID**

NCT05137002

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**ClinicalTrials.gov ID**

NCT05137002

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Quadruple masking

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

## Outcomes

### Primary outcomes

1. Change From Baseline in Mean Seated Systolic BP (SBP)  
Timeframe: 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).

### Secondary outcomes

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

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

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

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

## Sites

- CinCor Site 27Saraland, United States
- CinCor Site 35Tucson, United States
- CinCor Site 69Encinitas, United States
- CinCor Site 6Lincoln, United States
- CinCor Site 20Los Angeles, United States
- CinCor Site 70Lynwood, United States
- CinCor Site 36Northridge, United States
- CinCor Site 29Oceanside, United States
- CinCor Site 46Panorama City, United States
- CinCor Site 47San Dimas, United States
- CinCor Site 49Santa Ana, United States
- CinCor Site 52West Hills, United States
- CinCor Site 57Denver, United States
- CinCor Site 31Waterbury, United States
- CinCor Site 18Clearwater, United States
- CinCor Site 41Cooper City, United States
- CinCor Site 28Homestead, United States
- CinCor Site 9Jupiter, United States
- CinCor Site 1Lake Worth, United States
- CinCor Site 12Miami, United States
- CinCor Site 54Miami, United States
- CinCor Site 13Miami, United States
- CinCor Site 17Miami, United States
- CinCor Site 16Tampa, United States
- CinCor Site 34Winter Haven, United States

And 38 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137002)

## Related records

### Drugs (1)

- [Baxdrostat](https://trialight.com/data/asset/baxdrostat-a2e43871-8326-4540-9aa3-5a6511c12d97.md)

### Lead sponsors (1)

- [CinCor Pharma, Inc.](https://trialight.com/data/company/cincor-pharma-inc-ce295bab-099a-4a11-b51e-9d7b751136b4.md)

### Conditions (1)

- [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) Primary condition

### Targets (1)

- [CYP11B2](https://trialight.com/data/target/cyp11b2-a697aaba-f90f-5afc-8916-609c5358a8db.md)

---

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