A clinical study of MK-0616 for people with high amounts of low-density lipoprotein cholesterol

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

28 Sep 2023 → 7 Apr 2025

Decision date (initial)

2023-09-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2022-502782-14-00

WHO UTN

U1111-1285-4257

ClinicalTrials.gov

NCT05952869

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Pharmacodynamic, Pharmacogenetic, Safety, Therapy, Pharmacogenomic

1. To evaluate the efficacy of MK-0616 compared with placebo on mean percent change from baseline in LDL-C at Week 24.
2. To evaluate the safety and tolerability of MK-0616.

Secondary objectives 6

1. To evaluate the efficacy of MK-0616 compared with placebo on mean percent change from baseline in LDL-C at Week 52.
2. To evaluate the efficacy of MK-0616 compared with placebo on mean percent change from baseline in non-HDL-C at Week 24.
3. To evaluate the efficacy of MK-0616 compared with placebo on mean percent change from baseline in ApoB at Week 24.
4. To evaluate the efficacy of MK-0616 compared with placebo on percent change from baseline in Lp(a) at Week 24.
5. To evaluate the efficacy of MK-0616 compared with placebo on the proportion of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24.
6. To evaluate the efficacy of MK-0616 compared with placebo on the proportion of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24.

Conditions and MedDRA coding

Heterozygous Familial Hypercholesterolemia (HeFH)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
2. Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
3. Is treated with a moderate- or high-intensity statin medication
4. Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change

Exclusion criteria 4

1. Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
2. Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
3. Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
4. Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24
2. Number of participants with one or more adverse events (AEs)
3. Number of participants who discontinue study drug due to an AE

Secondary endpoints 6

1. Mean percent change from baseline in LDL-C at Week 52
2. Mean percent change from baseline in non-high-density lipoprotein cholesterol (HDL-C) at Week 24
3. Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24
4. Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24
5. Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24
6. Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Laura Gellis

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Laura Gellis

Third parties 6

Locations

6 EU/EEA countries · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 60 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications