NCT07230730

Brief Summary

The study is being conducted to evaluate the efficacy, and safety of SHR-1918 in reducing serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia compared with placebo, and also includes To evaluate the effectiveness of SHR-1918 in reducing other lipid indicators in patients with mixed hyperlipidemia and to assess the safety of SHR-1918 in patients with mixed hyperlipidemia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_3

Timeline
17mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jan 2026Oct 2027

First Submitted

Initial submission to the registry

September 22, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 13, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

February 2, 2026

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

September 22, 2025

Last Update Submit

January 30, 2026

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

  • The percentage change of serum LDL-C from baseline;

    Baseline and Week 24

  • The percentage change in serum TG from baseline;

    Baseline and Week 24

Secondary Outcomes (24)

  • Percentage change of serum non-high-density lipoprotein cholesterol (non-HDL-C) from baseline;

    Baseline and Week 24

  • The percentage change in serum total cholesterol (TC) from baseline;

    Baseline and Week 24

  • The percentage change of serum apolipoprotein B (ApoB) from baseline at week 24;

    Baseline and Week 24

  • The percentage change of serum apolipoprotein A1 (ApoA1) from baseline;

    Baseline and Week 24

  • The change from baseline in serum LDL-C；

    Baseline and Week 24

  • +19 more secondary outcomes

Study Arms (4)

SHR-1918 low dose

EXPERIMENTAL
Drug: SHR-1918

SHR-1918 placebo low dose

PLACEBO COMPARATOR
Drug: SHR-1918 placebo

SHR-1918 high dose

EXPERIMENTAL
Drug: SHR-1918

SHR-1918 placebo high dose

PLACEBO COMPARATOR
Drug: SHR-1918 placebo

Interventions

SHR-1918DRUG

SHR-1918

SHR-1918 high doseSHR-1918 low dose
SHR-1918 placeboDRUG

SHR-1918 placebo

SHR-1918 placebo high doseSHR-1918 placebo low dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the age must be at least 18 years old, and both men and women are eligible;
  • the patient was receiving a stable dose of statins at the time of screening,, and the fasting LDL-C met: For individuals with extremely high risk of ASCVD, LDL-C≥1.4 mmol/L; for those with very high risk of ASCVD, LDL-C≥1.8 mmol/L; and for those with medium and high risk of ASCVD, ≥2.6 mol/L;
  • Fasting TG≥2.3，and ≤5.6 mmol/L;
  • Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person；

You may not qualify if:

  • poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) at the time of screening or before randomization；
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or γ -glutamyl transferase (GGT) \> 3× upper limit of normal (ULN), or total bilirubin \> 2×ULN；
  • Thyroid stimulating hormone (TSH) is lower than the lower limit of normal (LLN) or greater than 1.5×ULN；
  • The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m2；
  • Previously suffering from diseases that have a significant impact on blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Sheng Qi

CONTACT

+86 0518 82342973Sheng.qi@hengrui.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2025

First Posted

November 17, 2025

Study Start

January 13, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

February 2, 2026

Record last verified: 2025-09

Locations

CN(1)