Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol study: BEBT-701 Injection
Official title A Study of BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol（LDL-C）
ClinicalTrials.gov ID: NCT07368608
What this study is testing
What is BEBT-701 Injection?
An investigational once‑subcutaneous injectable medicine being studied for mild to moderate hypertension and elevated LDL‑C.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe the drug is, how it moves through the body, and whether it might lower blood pressure and cholesterol.
- Who it's for
- It is for adults who have mild to moderate high blood pressure and high LDL cholesterol.
- What's involved
- Participants will receive a single injection in the first part of the study and then several injections over time. They will have regular check‑ups and blood tests to monitor safety and drug levels.
- Time commitment
- The study lasts about 6 to 12 months, with several clinic visits for injections and monitoring.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Male or female aged 18 to 60 years (inclusive).
- people with essential hypertension who are either treatment-naive or have remained off any antihypertensive medication for ≥ 30 days prior to...
- Body-mass index (BMI) 18.6-30kg/m² (inclusive); body weight ≥ 50 kg for men and ≥ 45 kg for women.
- Has maintained a stable diet for at least 4 weeks before screening and has no plan to make a clinically significant change in diet or body weight...
- Agrees to use a highly effective method of contraception and to avoid becoming a parent from enrollment until 12 months after the last dose.
You likely can't join if
- Any history of severe illness-apart from hypertension and hyperlipidemia-that in the investigator's opinion could influence trial outcomes, including...
- History of allergic disease or atopic diathesis (≥3 drug or food allergies), or known hypersensitivity to oligonucleotide-based therapeutics.
- Use of anti-PCSK9 or anti-AGT antibody agents within 6 months before screening, or of PCSK9- or AGT-targeted oligonucleotide drugs within 12 months...
- Malignancy within 5 years before informed-consent signature (exceptions: adequately resected and cured basal- or squamous-cell skin carcinoma...
- Left-ventricular ejection fraction (LVEF) \< 40% at screening; or significant aortic or peripheral vascular disease, or any vascular condition...
- Type 1 diabetes, or type 2 diabetes with inadequate glycaemic control (HbA1c ≥ 8%).
See the full eligibility criteria
Who can join
- Male or female aged 18 to 60 years (inclusive).
- people with essential hypertension who are either treatment-naive or have remained off any antihypertensive medication for ≥ 30 days prior to screening and in whom the investigator deems no additional antihypertensive...
- Body-mass index (BMI) 18.6-30kg/m² (inclusive); body weight ≥ 50 kg for men and ≥ 45 kg for women.
- Has maintained a stable diet for at least 4 weeks before screening and has no plan to make a clinically significant change in diet or body weight during the study (a change \> 10 % is considered significant).
- Agrees to use a highly effective method of contraception and to avoid becoming a parent from enrollment until 12 months after the last dose.
- At screening and within 24 h before randomization, the 24-h ambulatory blood-pressure monitoring shows mean systolic blood pressure (SBP) \> 130 mmHg and \< 150 mmHg.
- At screening and within 24h before randomization, 24-h ambulatory blood-pressure monitoring must show mean SBP \> 130 mmHg and \< 160 mmHg.
- At screening and baseline, fasting serum LDL-C ≥ 100 mg/dL (2.6 mmol/L). people already on statin therapy must have been on a stable statin dose and regimen for at least 30 days prior to screening and must have no...
What rules you out
- Any history of severe illness-apart from hypertension and hyperlipidemia-that in the investigator's opinion could influence trial outcomes, including but not limited to diseases of the circulatory system (e.g...
- History of allergic disease or atopic diathesis (≥3 drug or food allergies), or known hypersensitivity to oligonucleotide-based therapeutics.
- Use of anti-PCSK9 or anti-AGT antibody agents within 6 months before screening, or of PCSK9- or AGT-targeted oligonucleotide drugs within 12 months before screening.
- Malignancy within 5 years before informed-consent signature (exceptions: adequately resected and cured basal- or squamous-cell skin carcinoma, cervical carcinoma in situ, or other cancers considered cured by surgery...
- Left-ventricular ejection fraction (LVEF) \< 40% at screening; or significant aortic or peripheral vascular disease, or any vascular condition requiring surgical intervention.
- Type 1 diabetes, or type 2 diabetes with inadequate glycaemic control (HbA1c ≥ 8%).
- Major surgery within 6 months before dosing, or planned major surgery during the study period.
- Estimated glomerular filtration rate (eGFR) \ 300 mg/g at screening.
- At screening, any of the following laboratory abnormalities: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin(TBIL),gamma-glutamyl transferase(GGT), or alkaline phosphatase(ALP) \> 1.5 ×...
- Mean 24-h ambulatory diastolic blood pressure (DBP) \> 110 mmHg at screening and/or within 24 h prior to randomization (one repeat measurement permitted).
- QT/QTc prolongation at screening or baseline: QT interval corrected by Fridericia's formula (QTcF)≥ 450 ms (men) or ≥ 460 ms (women).
- Positive serology for HBsAg, anti-hepatitis C virus(HCV), HCV core antigen, anti-human immunodeficiency virus (HIV), or Treponema pallidum antibody
- Known or suspected secondary hypertension, including but not limited to bilateral renal-artery stenosis, primary aldosteronism, pheochromocytoma, polycystic kidney disease, or drug-induced hypertension.
- Occupations involving hazardous operations such as piloting vessels or working at height.
- Subcutaneous-injection intolerance, or prominent abdominal scarring, tattoos, or other conditions that could materially interfere with study-drug administration or the assessment of local side effects.
- Blood loss or donation \> 400 mL within 3 months before dosing (menstrual bleeding excluded) and/or platelet donation within 2 weeks.
- Use, within 28 days before dosing, of any drug, nutraceutical, vitamin, or dietary supplement known to affect lipid metabolism.
- History of drug abuse or positive urine drug screen, and/or use of illicit drugs within 3 months before screening, and/or habitual use of any psychoactive substance (including herbal preparations).
- Average daily consumption \> 5 cigarettes (or equivalent e-cigarette use) within 3 months before screening and/or unwillingness to abstain from all tobacco products during the study.
- Regular alcohol consumption within 6 months before screening (i.e., \> 14 units/week; 1 unit = 360 mL of 5% beer, 45 mL of 40% spirits, or 150 mL of 12% wine) and inability to comply with alcohol-restriction...
- Daily intake of excessive tea, coffee, and/or caffeine-containing beverages (≥ 8 cups/day; 1 cup = 250 mL) within 1 month before screening.
- Participation in any clinical trial within 3 months before screening (12 months for oligonucleotide investigational drugs).
- people who, for any other reason, are unlikely to complete the study or whom the investigator deems should not be enrolled.
- Pregnant or lactating women.
- History of syncope within 3 months before screening.
- Receipt of a live vaccine within 4 weeks before screening or planned live-vaccine administration during the study.
- Use of long-acting estrogen and/or progestin injections or implants within 6 months before dosing.
- Women of child-bearing potential who engaged in unprotected intercourse with a partner within 28 days before dosing.
The study team makes the final eligibility decision.
Where it is enrolling
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Changsha, Hunan, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.