NCT07368608

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: BeBetter Med Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-26
• Primary completion: 2028-11-30
• Completion: 2029-06-30
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: China