Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein CholesterolPhase 1/2NCT07368608
A Study of BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol(LDL-C)
A Phase 1/2 study testing BEBT-701 Injection in people with Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol, run by BeBetter Med Inc at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol
- What is being tested?
- BEBT-701 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Jun 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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%).
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- 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.
- 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 requirements during the study.
- 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).
- Subjects 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Ju Yang, Bachelor, +86-13408523335, ju.yang@bebettermed.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated LDL-C
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.
Read the detailed description
This study employs an integrated Phase I/II seamless adaptive design. Stage 1 is a single-dose Phase I component, randomized, double-blind, and placebo-controlled, with five pre-specified dose cohorts starting at 100 mg. Its primary objectives are to characterize the safety, tolerability, PK, PD, and preliminary efficacy of single-dose BEBT-701 across the planned dose range, thereby providing critical input for dose and dosing-interval selection for Stage 2.
After a 2- to 4-week observation period following the last Phase I cohort, three doses (preliminary) will be selected from the accumulated data to initiate Stage 2, a multiple-dose Phase II segment. This stage is a randomized, double-blind, parallel-group comparison of three active dose levels versus placebo. Placebo recipients will crossover to active treatment at Week 12 after the second dose; active-arm subjects will enter a double-blind extension after completing the 24-week post-second-dose visit, enabling collection of longer-term safety and efficacy data.
- Being tested
- BEBT-701 Injection, BEBT-701 Injection Placebo(0.9% Sodium Chloride Injection)
- Keywords
- BEBT-701, Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEBT-701 InjectionDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: BEBT-701 Injection Placebo(0.9% Sodium Chloride Injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 36 months
Low-Density Lipoprotein Cholesterol(LDL-C)
Percentage change from baseline in LDL-C after dosing.
Measured: Up to 24 weeks
24hour-Ambulatory Blood Pressure Monitoring(24h-ABPM)
Change from baseline in mean 24h-ABPM systolic blood pressure (SBP) after dosing.
Measured: Up to 24weeks
Secondary outcomes (8)
AUC0-∞
The area under the plasma concentration-time curve from time zero to infinity.
Measured: 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
The maximum plasma drug concentration
Measured: 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
The time to reach maximum plasma drug concentration
Measured: 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
The time for plasma drug concentration to halve
Measured: 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
Percentage change from baseline in mean 24-h ABPM SBP; Change from baseline in mean 24-h ABPM SBP; Change from baseline and percentage change from baseline in mean 24-h ABPM DBP,standard daytime mean SBP and DBP (6 a.m.-10 p.m.), standard nighttime mean SBP and DBP (10 p.m.-6 a.m.); Change from baseline and percentage change from baseline in office seated SBP, DBP, and mean arterial pressure (MAP).
Measured: Up to 24 weeks
Lipid-related parameters
Percentage change from baseline in LDL-C;Change from baseline and percentage change from baseline in total cholesterol (TC), high-density-lipoprotein cholesterol (HDL-C), non-high-density-lipoprotein cholesterol (non-HDL-C), very-low-density-lipoprotein cholesterol (VLDL-C), apolipoprotein B, apolipoprotein A1, triglycerides, and lipoprotein(a).
Measured: Up to 24 weeks
Angiotensinogen(AGT)
Change from baseline and percentage change from baseline in AGT.
Measured: Up to 36 weeks
Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Change from baseline and percentage change from baseline in PCSK9.
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Mar 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein CholesterolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeBetter Med Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Yuan, Ph.D, Principal investigator, The Third Xiangya Hospital of Central South UniversityGuoping Yang, Ph.D, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368608
- Sponsor's protocol ID
- GBMT-701-P01
- Status last verified
- Aug 2026
- First submitted
- 20 Jan 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated LDL-C
- ClinicalTrials.gov ID
- NCT07368608
- Acronym / sponsor ID
- GBMT-701-P01
- Keywords
- BEBT-701, Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- BeBetter Med IncIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study employs an integrated Phase I/II seamless adaptive design. Stage 1 is a single-dose Phase I component, randomized, double-blind, and placebo-controlled, with five pre-specified dose cohorts starting at 100 mg. Its primary objectives are to characterize the safety, tolerability, PK, PD, and preliminary efficacy of single-dose BEBT-701 across the planned dose range, thereby providing critical input for dose and dosing-interval selection for Stage 2.
After a 2- to 4-week observation period following the last Phase I cohort, three doses (preliminary) will be selected from the accumulated data to initiate Stage 2, a multiple-dose Phase II segment. This stage is a randomized, double-blind, parallel-group comparison of three active dose levels versus placebo. Placebo recipients will crossover to active treatment at Week 12 after the second dose; active-arm subjects will enter a double-blind extension after completing the 24-week post-second-dose visit, enabling collection of longer-term safety and efficacy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I Single-Dose Cohorts (BEBT-701) | Experimental | Drug: BEBT-701 InjectionPhase 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. |
| Phase I Single-Dose Cohorts (Placebo) | Placebo comparator | Drug: BEBT-701 Injection Placebo(0.9% Sodium Chloride Injection)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. |
| Phase II Multiple-Dose Cohorts (BEBT-701) | Experimental | Drug: BEBT-701 InjectionPhase 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. |
| Phase II Multiple-Dose Cohorts (Placebo) | Placebo comparator | Drug: BEBT-701 Injection Placebo(0.9% Sodium Chloride Injection)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEBT-701 InjectionPhase 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. | Drug | Phase I Single-Dose Cohorts (BEBT-701), Phase II Multiple-Dose Cohorts (BEBT-701) |
| BEBT-701 Injection Placebo(0.9% Sodium Chloride Injection)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. | Drug | Phase I Single-Dose Cohorts (Placebo), Phase II Multiple-Dose Cohorts (Placebo) |
Primary outcome
Occurrence of Adverse Events (AEs)
Time frame: Up to 36 months
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).
Low-Density Lipoprotein Cholesterol(LDL-C)
Time frame: Up to 24 weeks
Percentage change from baseline in LDL-C after dosing.
24hour-Ambulatory Blood Pressure Monitoring(24h-ABPM)
Time frame: Up to 24weeks
Change from baseline in mean 24h-ABPM systolic blood pressure (SBP) after dosing.
8 secondary outcomes
AUC0-∞
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 24 weeks
Lipid-related parameters
Time frame: Up to 24 weeks
Angiotensinogen(AGT)
Time frame: Up to 36 weeks
Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Time frame: Up to 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong Yuan, Ph.D principal investigator
The Third Xiangya Hospital of Central South University
Guoping Yang, Ph.D principal investigator
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BEBT-701 Injection in people with Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol, run by BeBetter Med Inc at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kegang Jiang, Master (+86-18664786382, kjiang@bebettermed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Adverse Events (AEs) (time frame: Up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.