A Study of VCT220 in Participants With Hypertension and Obesity or Overweight (VICTOR-HTN)

Vincentage Pharma Co., Ltd

Status and phase: Begins enrollment this month; Phase 2

Conditions: Hypertension

Treatments: Drug: VCT220 Tablet; Drug: VCT220 Placebo Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT07360275

VCT220-II-03

Details and patient eligibility

About

The purpose of this study is to explore the safety and efficacy of VCT220 for the treatment of hypertension in participants with obesity or overweight.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Male or female participants aged 18 to 75 years (inclusive) at the time of screening.
2. Body mass index (BMI) ≥ 24 kg/m² at screening.
3. Diagnosed with primary hypertension, with office seated systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg at both screening and baseline.
4. Either treatment-naïve to antihypertensive therapy for ≥ 30 days prior to screening, or receiving a stable dose for ≥ 30 days of one or two of the following classes of antihypertensive medications: renin-angiotensin system inhibitors (ARB/ACEI), calcium channel blockers (CCB), or diuretics.
5. Has at least one self-reported history of unsuccessful weight loss through dietary control.
6. Willing and able to maintain a stable residence and remain contactable throughout the study, and to adhere to regular lifestyle routines as well as dietary and exercise management during the trial.
7. Has a full understanding of the study procedures, is able to communicate effectively with the investigator, understands and is willing to comply with all study requirements, and voluntarily provides written informed consent.

Exclusion Criteria

1. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
2. History of or current secondary hypertension.
3. Office seated systolic blood pressure (SBP) ≥ 170 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg at screening or baseline, or presence of a hypertensive emergency.
4. A decrease in office seated SBP of ≥ 20 mmHg or a decrease in office seated DBP of ≥ 10 mmHg at baseline compared with screening.
5. Presence of orthostatic hypotension at screening, defined as a decrease in office SBP of ≥ 15 mmHg or DBP of ≥ 7 mmHg upon transition from the seated to standing position.
6. A difference of ≥ 20 mmHg in office seated SBP between the left and right upper arms at screening or baseline.
7. Treatment with any marketed or investigational drug with a glucagon-like peptide-1 (GLP-1) receptor agonist mechanism within 1 year prior to screening.
8. Self-reported or documented body weight change of ≥ 5 kg within 3 months prior to screening.
9. History of or current type 1 or type 2 diabetes mellitus.
10. History of or current malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
11. History of or current major cardiovascular or cerebrovascular disease.
12. History of or current severe gastrointestinal disease or prior major gastrointestinal surgery.
13. Clinically significant active or unstable severe major depressive disorder or other severe psychiatric disorders within 2 years prior to screening; or any history of suicide attempt.
14. Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at screening, or a positive response to Item 9.
15. Pregnant or breastfeeding women; or men or women of childbearing potential who are unwilling to use highly effective contraception throughout the study and for 3 months after the last dose, or who plan to conceive, donate sperm, or donate oocytes during this period; or women with a positive pregnancy test at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups, including a placebo group

VCT220 80mg

Experimental group

Description:

Participants will receive VCT220 orally everyday. Starting from 20mg and maintaining at 80mg

Treatment:

Drug: VCT220 Tablet

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally.

Treatment:

Drug: VCT220 Placebo Tablet

VCT220 160mg (1)

Experimental group

Description:

Participants will receive VCT220 orally everyday. Starting from 20mg and maintaining at 160mg

Treatment:

Drug: VCT220 Tablet

VCT220 160mg (2)

Experimental group

Description:

Participants will receive VCT220 orally everyday. Starting from 40mg and maintaining at 160mg

Treatment:

Drug: VCT220 Tablet