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

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of VCT220 in Participants With Hypertension and Obesity or Overweight.

Обзор

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.

Вмешательства

• Препарат VCT220 Tablet
  Administered orally, with or without food.
• Препарат VCT220 Placebo Tablet
  Administered orally, with or without food.

Первичные конечные точки

• Change from baseline in office seated systolic blood pressure (SBP) at Week 20 [Срок оценки: From baseline to week 20]

Вторичные конечные точки (6)

• Change from baseline in office seated diastolic blood pressure (DBP) at Week 20 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From baseline to week 20]
• Changes in body weight at week 20 [Срок оценки: From baseline to week 20]
• Adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) [Срок оценки: From baseline to week 20]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Beijing Luhe Hospital — Пекин
• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07360275 · VCT220-II-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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