A Study of BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol（LDL-C）

NCT07368608 | Not Yet Recruiting Phase 1

• 1 other identifier: GBMT-701-P01
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I/II clinical trial is designed to evaluate, through a single-dose Phase I segment and a multiple-dose Phase II segment, the safety/tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) characteristics of BEBT-701 administered by subcutaneous injection in patients with mild to moderate hypertension and elevated LDL-C , and to explore its preliminary efficacy.

Conditions

Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol

Keywords

BEBT-701; Safety; Tolerability; Pharmacokinetics; Preliminary Efficacy

Outcome Measures

Primary Outcomes (3)

• Occurrence of Adverse Events (AEs)

  Occurrence of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE V5.0).

  Up to 36 months

• Low-Density Lipoprotein Cholesterol(LDL-C)

  Percentage change from baseline in LDL-C after dosing.

  Up to 24 weeks

• 24hour-Ambulatory Blood Pressure Monitoring（24h-ABPM）

  Change from baseline in mean 24h-ABPM systolic blood pressure (SBP) after dosing.

  Up to 24weeks

Secondary Outcomes (8)

• AUC0-∞

  Phase I:From pre-dose to 72 h post-dose on Day 1; Phase II:From pre-dose to 72 h post-dose on Day 1and Day 85.

• Cmax

  Phase I:From pre-dose to 72 h post-dose on Day 1; Phase II:From pre-dose to 72 h post-dose on Day 1and Day 85.

• Tmax

  Phase I:From pre-dose to 72 h post-dose on Day 1; Phase II:From pre-dose to 72 h post-dose on Day 1and Day 85.

• t1/2

  Phase I:From pre-dose to 72 h post-dose on Day 1; Phase II:From pre-dose to 72 h post-dose on Day 1and Day 85.

• Blood pressure-related parameters

  Up to 24 weeks

Other Outcomes (1)

• Immunogenicity parameters

  Up to 36 weeks

Study Arms (4)

Phase I Single-Dose Cohorts (BEBT-701)

EXPERIMENTAL

Phase I: Five predefined dose cohorts are planned. In each cohort, the first two subjects (randomized 1:1 to active drug or placebo) are dosed in a sentinel fashion. Only after these two subjects have completed at least 48 h of safety observation and the investigator has confirmed acceptable tolerability will the remaining six subjects be enrolled and dosed at a 5:1 ratio (active drug : placebo). Enrollment and dosing of the next higher dose cohort will begin only after every subject in the preceding cohort has completed a minimum 2-week safety observation period and the safety data are judged acceptable.

Drug: BEBT-701 Injection

Phase I Single-Dose Cohorts (Placebo)

PLACEBO COMPARATOR

Phase I: Five predefined dose cohorts are planned. In each cohort, the first two subjects (randomized 1:1 to active drug or placebo) are dosed in a sentinel fashion. Only after these two subjects have completed at least 48 h of safety observation and the investigator has confirmed acceptable tolerability will the remaining six subjects be enrolled and dosed at a 5:1 ratio (active drug : placebo). Enrollment and dosing of the next higher dose cohort will begin only after every subject in the preceding cohort has completed a minimum 2-week safety observation period and the safety data are judged acceptable.

Drug: BEBT-701 Injection Placebo（0.9% Sodium Chloride Injection）

Phase II Multiple-Dose Cohorts (BEBT-701)

EXPERIMENTAL

Phase II: Based on the preliminary safety, PK, and PD data from the Phase I single-dose study, three dose levels will be selected for further evaluation. Eligible subjects will be randomized in a 1:1:1:1 ratio to one of the three pre-specified active doses or to placebo.

Drug: BEBT-701 Injection

Phase II Multiple-Dose Cohorts (Placebo)

PLACEBO COMPARATOR

Phase II: Based on the preliminary safety, PK, and PD data from the Phase I single-dose study, three dose levels will be selected for further evaluation. Eligible subjects will be randomized in a 1:1:1:1 ratio to one of the three pre-specified active doses or to placebo.

Drug: BEBT-701 Injection Placebo（0.9% Sodium Chloride Injection）

Interventions

BEBT-701 Injection DRUG

Phase I: The starting dose of BEBT-701 injection is 100 mg; the single subcutaneous doses are 100 mg, 200 mg, 400 mg, 800 mg, and 1200 mg. Phase II: Based on the preliminary Phase I findings, three dose levels will be selected for the Phase II study, with BEBT-701 injection administered subcutaneously on Day 1 and Day 85.

Phase I Single-Dose Cohorts (BEBT-701); Phase II Multiple-Dose Cohorts (BEBT-701)

BEBT-701 Injection Placebo（0.9% Sodium Chloride Injection） DRUG

Phase I：BEBT-701 injection placebo, administered as a single subcutaneous dose. Phase II:BEBT-701 injection placebo administered subcutaneously on Day 1 and Day 85.

Phase I Single-Dose Cohorts (Placebo); Phase II Multiple-Dose Cohorts (Placebo)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged 18 to 60 years (inclusive).
• Subjects 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 therapy necessary during the study period.
• 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.
• Able to understand the study requirements, willing to comply, and provides written informed consent.
• Phase I subjects must simultaneously meet the following criteria:
• 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 baseline, fasting serum LDL-C is ≥ 100 mg/dL (2.6 mmol/L) and \< 190 mg/dL (4.9 mmol/L) in subjects who are either lipid-lowering-therapy-naive or have not received any lipid-lowering drug within 30 days before screening and whom the investigator judges will not require any additional lipid-lowering therapy during the study.
• Phase II subjects must simultaneously meet the following criteria:
• 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). Subjects 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 planned changes to their statin treatment during the study.

You may not qualify if:

• 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., orthostatic hypotension, NYHA class II-IV heart failure, aortic stenosis, major aortic aneurysm or dissection, hypertensive encephalopathy, acute stroke, transient ischemic attack, acute myocardial infarction, significant arrhythmias), endocrine, neurologic, gastrointestinal, genitourinary, hematologic, immunologic, psychiatric, or metabolic disorders.
• 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 alone).
• 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) \< 60 mL/min/1.73 m² (by simplified MDRD equation) or urine albumin-to-creatinine ratio (UACR) \> 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 × upper limit of normal (ULN), or serum potassium \> 5.5 mmol/L (one repeat measurement permitted).
• 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; if Treponema pallidum antibody is positive, a confirmatory rapid plasma reagin(RPR) test is required and must also be positive.
• 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 tolerability.

Sponsors & Collaborators

• BeBetter Med Inc: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Study Officials

• Hong Yuan, Ph.D

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Guoping Yang, Ph.D

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kegang Jiang, Master

CONTACT

+86-18664786382; kjiang@bebettermed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 20, 2026
• First Posted: January 26, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

CN (1)