Extension trial for adults with high cholesterol who completed a MK-0616 clinical trial

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

23 Aug 2024 → ongoing

Decision date (initial)

2024-08-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-504922-20-00

WHO UTN

U1111-1290-3950

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To evaluate the safety and tolerability of enlicitide treatment

Secondary objectives 3

1. To evaluate the efficacy of enlicitide on percent change from baseline of the parent study in LDL-C at Week 8 of the OLE
2. To evaluate the efficacy of enlicitide on percent change from baseline of the parent study in non-HDL-C, ApoB, and Lp(a) at Week 8 of the OLE
3. To evaluate the efficacy of enlicitide on the proportion of participants with LDL-C <70 mg/dL and ≥50% reduction, and <55 mg/dL and ≥50% reduction from baseline of the parent study over time

Conditions and MedDRA coding

Hypercholesterolemia

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 2

1. Has completed an enlicitide (also known as enlicitide decanoate and MK-0616) parent study (MK-0616-013, MK-0616-017, MK-0616-018) per protocol including the final assessments/procedure of their parent study
2. Had overall study compliance ≥80% while participating in their parent study

Exclusion criteria 4

1. Had discontinued study intervention in their parent study
2. Has an ongoing serious adverse event (SAE) considered related to study intervention by the investigator in the parent study
3. Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
4. Is currently participating in an interventional clinical study other than an enlicitide parent study (i.e., MK-0616-013, MK-0616-017, MK-0616-018)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Number of participants with one or more adverse events (AEs)
2. Number of participants who discontinue study drug due to an AE

Secondary endpoints 6

1. Percent change from baseline of the parent study in low-density lipoprotein cholesterol (LDL-C) at Week 8 of this extension study
2. Percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this extension study
3. Percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study
4. Percent change from baseline of the parent study in lipoprotein(a) (Lp[a]) at Week 8 of this extension study
5. Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline of the parent study
6. Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline of the parent study

Investigational products

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

Test 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 3

Locations

9 EU/EEA countries · 43 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

Documents 41 files

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

Application history

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