A Study of VCT220 in Participants With Hypertension and Obesity or Overweight

NCT07360275 | Not Yet Recruiting Phase 2

• 1 other identifier: VCT220-II-03
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in office seated systolic blood pressure (SBP) at Week 20

  Measured In mmHg

  From baseline to week 20

Secondary Outcomes (6)

• Change from baseline in office seated diastolic blood pressure (DBP) at Week 20

  From baseline to week 20

• Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) systolic blood pressure and diastolic blood pressure at Week 20

  From baseline to week 20

• Proportion of participants achieving the standard blood pressure target (< 140/90 mmHg) based on office seated blood pressure at Week 20

  From baseline to week 20

• Proportion of participants achieving the intensive blood pressure target (< 130/80 mmHg) based on office seated blood pressure at Week 20

  From baseline to week 20

• Changes in body weight at week 20

  From baseline to week 20

Study Arms (4)

VCT220 80mg

EXPERIMENTAL

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

Drug: VCT220 Tablet

Placebo

PLACEBO COMPARATOR

Participants will receive placebo orally.

Drug: VCT220 Placebo Tablet

VCT220 160mg (1)

EXPERIMENTAL

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

Drug: VCT220 Tablet

VCT220 160mg (2)

EXPERIMENTAL

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

Drug: VCT220 Tablet

Interventions

VCT220 Tablet DRUG

Administered orally, with or without food.

VCT220 160mg (1); VCT220 160mg (2); VCT220 80mg

VCT220 Placebo Tablet DRUG

Administered orally, with or without food.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged 18 to 75 years (inclusive) at the time of screening.
• Body mass index (BMI) ≥ 24 kg/m² at screening.
• 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.
• 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.
• Has at least one self-reported history of unsuccessful weight loss through dietary control.
• 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.
• 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.

You may not qualify if:

• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
• History of or current secondary hypertension.
• 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.
• A decrease in office seated SBP of ≥ 20 mmHg or a decrease in office seated DBP of ≥ 10 mmHg at baseline compared with screening.
• 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.
• A difference of ≥ 20 mmHg in office seated SBP between the left and right upper arms at screening or baseline.
• Treatment with any marketed or investigational drug with a glucagon-like peptide-1 (GLP-1) receptor agonist mechanism within 1 year prior to screening.
• Self-reported or documented body weight change of ≥ 5 kg within 3 months prior to screening.
• History of or current type 1 or type 2 diabetes mellitus.
• 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.
• History of or current major cardiovascular or cerebrovascular disease.
• History of or current severe gastrointestinal disease or prior major gastrointestinal surgery.
• 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.
• Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at screening, or a positive response to Item 9.
• 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.

Sponsors & Collaborators

• Vincentage Pharma Co., Ltd: lead

Study Sites (2)

Beijing Luhe Hospital

Beijing, Beijing Municipality, 100044, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Miles Zhang

CONTACT

86+18210070401; bd@vincentage.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 22, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

CN (2)