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

NCT07368608 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-01-26

No results posted yet for this study

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

Interventions

DRUG

BEBT-701 Injection

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.

DRUG

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.

Sponsors & Collaborators

  • BeBetter Med Inc

    lead INDUSTRY

Principal Investigators

  • Hong Yuan, Ph.D · The Third Xiangya Hospital of Central South University

  • Guoping Yang, Ph.D · The Third Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-26
Primary Completion
2028-11-30
Completion
2029-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07368608 on ClinicalTrials.gov