NCT07349615

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypertriglyceridemia. The efficacy and safety of SHR-1918 will be evaluated after 24-weeks and 48-weeks treatment.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
18mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress15%
Feb 2026Nov 2027

First Submitted

Initial submission to the registry

January 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

January 13, 2026

Last Update Submit

February 5, 2026

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • Percentage change in mean serum triglyceride (TG) levels at Week 20 and Week 24 relative to baseline

    at 20 weeks and 24 weeks of treatment

Secondary Outcomes (24)

  • Percentage change in non-HDL-C relative to baseline

    at 24 weeks of treatment

  • Percentage change in LDL-C relative to baseline；

    at 24 weeks of treatment

  • Percentage change in TC relative to baseline；

    at 24 weeks of treatment；

  • Percentage change in ApoB relative to baseline；

    at 24 weeks of treatment；

  • Percentage change in ApoA1 relative to baseline；

    at 24 weeks of treatment；

  • +19 more secondary outcomes

Study Arms (2)

SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection；

EXPERIMENTAL
Drug: SHR-1918/ SHR-1918 placebo

SHR-1918/ SHR-1918 placebo Group B, subcutaneous injection；

EXPERIMENTAL
Drug: SHR-1918/ SHR-1918 placebo

Interventions

SHR-1918/ SHR-1918 placeboDRUG

SHR-1918/ SHR-1918 placebo Dose 1

SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection；

Eligibility Criteria

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

You may qualify if:

  • Male and female ≥ 18 years old, who is able and willing to provide a written informed consent.
  • ≤ TG ≤ 5.6 mmol/L.
  • LDL-C \< 3.4 mmol/L.
  • Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and after the last dose, and agree to use contraceptive methods as specified in the protocol.

You may not qualify if:

  • History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.
  • Received or are currently receiving treatment with monoclonal antibodies, siRNA-based drugs, or ASO-based drugs targeting the same target prior to screening.
  • Have a history of pancreatitis prior to screening or randomization.
  • Acute ischemic ASCVD events within 3 months prior to screening or randomization.
  • Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
  • Malignant tumors within 5 years.
  • Received plasma exchange therapy within 2 months prior to screening, or plans to receive plasma exchange therapy during the study period, or has received LDL receptor gene therapy prior to screening.
  • Have a history of diseases that significantly affect blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, or have severe arrhythmia prior to screening or randomization.
  • Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
  • Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Miaomiao Shi

CONTACT

18036617171Miaomiao.shi@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

January 13, 2026

First Posted

January 20, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

CN(1)