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NCT06009393 Clinical Trial

Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

Homozygous Familial Hypercholesterolemia Clinical Trial

Official title:
A Single-Arm, Open-Label, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06009393
Other study ID # SHR-1918-202
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 24, 2023
Est. completion date August 18, 2024

Study information
Verified date August 2023
Source Beijing Suncadia Pharmaceuticals Co., Ltd
Contact Meng Sun
Phone +86 18036618718
Email meng.sun@hengrui.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single-arm, open-label study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date August 18, 2024
Est. primary completion date June 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol 2. LDL-C =2.6mmol/L at the screening visit 3. Body weight =40 kg 4. Receiving stable lipid-lowering therapy for at least 28 days before enrollment. Exclusion Criteria: 1. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c > 8.5%) 2. eGFR <30ml/min/1.73m2 at the screening visit 3. CK >5times ULN at the screening visit

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SHR-1918
Three administration

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Beijing Suncadia Pharmaceuticals Co., Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change in calculated LDL-C from baseline to week 12 from baseline to week 12
Secondary Change in calculated LDL-C from baseline to week 12 from baseline to week 12
See also
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Recruiting NCT06125847 - NGGT006 Gene Therapy for Homozygous Familial Hypercholesterolemia Early Phase 1
Completed NCT01878604 - Gene Analysis and Treatment Optimization in Chinese Homozygous Familial Hypercholesterolemia N/A
Completed NCT01412034 - Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) Subjects Phase 2
Withdrawn NCT02765841 - Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy Phase 3
Completed NCT03933293 - A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH Phase 2
Completed NCT00704535 - Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
Recruiting NCT02135705 - LOWER: Lomitapide Observational Worldwide Evaluation Registry
Completed NCT03409744 - Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia Phase 3
Completed NCT04233918 - Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia Phase 3
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Terminated NCT01841684 - Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042) Phase 3
Recruiting NCT01109368 - The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository
Completed NCT01556906 - Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor Phase 2
Active, not recruiting NCT03135184 - HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia N/A
Recruiting NCT04815005 - HoFH, the International Clinical Collaborators Registry
Completed NCT03399786 - Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia Phase 3
Completed NCT03851705 - A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH) Phase 3
Completed NCT02265952 - Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH) Phase 2