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Phase 2 study of MK-7262 and enlicitide decanoate in adults with high lipoprotein(a)

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What is this study about?

The study focuses on adults who have Elevated lipoprotein(a), a blood protein that can increase the risk of heart disease. High levels of this protein, often called Lp(a), together with high LDL-C (the “bad” cholesterol) are linked to more plaque buildup in arteries.

The investigation tests a new oral medication called MK-7262 alone and in combination with a second oral agent, enlicitide decanoate. The goal is to see whether these medicines can lower the amount of the protein and the bad cholesterol more than a dummy pill (placebo).

Participants will take the assigned tablets once daily for several weeks, with regular check‑ins at the clinic to collect blood samples and report any side effects. The study lasts about two months, after which safety and how well the medicines worked are assessed.

1 baseline visit

you attend a first visit where the study staff confirm that you meet the eligibility criteria and collect blood samples to measure your current levels of lipoprotein(a) and ldl-c. after this assessment you are randomly assigned to receive either mk-7262, enlicitide decanoate, the combination of both, or a matching placebo. the study medication is provided in tablet form for oral use.

2 start study medication

you begin taking the assigned tablet each day. the exact dose is not disclosed in the study information, but the tablet is taken by mouth once daily. you continue this dosing for the entire 12‑week treatment period.

3 daily dosing period

throughout weeks 1 to 12 you take the study tablet at the same time each day, preferably with water and without food restrictions unless instructed otherwise. you keep a record of each dose taken and report any side effects to the study staff.

4 week 4 safety check

at the end of week 4 you return for a safety visit. blood is drawn again to monitor any changes in laboratory values and to check for possible adverse events (unwanted medical problems). the study staff ask about how you feel and whether you have experienced any new symptoms.

5 week 8 primary assessment

at week 8 you attend a major study visit. blood samples are taken to determine the percent change from baseline in lipoprotein(a) and ldl-c. these measurements are the primary outcomes of the trial. the staff also review any adverse events you may have had and decide whether the medication should be continued.

6 week 12 final assessment

at week 12 you complete the final study visit. additional blood tests evaluate the percent change from baseline in lipoprotein(a) and ldl-c at this later time point. a full safety review is performed, including documentation of any adverse events that occurred during the study.

7 study completion

after the week 12 visit you stop taking the study medication. the study staff may discuss the overall results with you and provide information about any follow‑up that might be needed.

Who Can Join the Study?

  • You must have an elevated level of Lp(a) (a type of cholesterol particle) that is 150 nmol/L or higher.
  • You need to be taking a statin medication at an optimized and stable dose for at least 30 days, and you cannot plan to add, change, or stop the statin during the study.
  • You can be either male or female, and you must fall within the age range required by the study.

Who Cannot Join the Study?

  • Having a past diagnosis of homozygous familial hypercholesterolemia (a genetic condition that causes very high cholesterol), compound heterozygous FH, or double heterozygous FH.
  • Having a history of serious heart problems such as class IV heart failure (the most severe form of heart failure), severe ventricular systolic dysfunction (weak heart pumping), uncontrolled irregular heart rhythm (ventricular arrhythmia), a very long heart‑rate test result (prolonged corrected QT interval), untreated high blood pressure (hypertension), or a recent heart attack, stroke, or major blood‑vessel blockage and surgery (coronary, cerebrovascular, or peripheral ischemic event or arterial revascularization).
  • Having a human immunodeficiency virus (HIV) infection that is not well‑controlled (i.e., viral load is detectable).
  • Having an active infection with hepatitis C virus or an active or chronic infection with hepatitis B virus (both are liver infections).
  • Having a past diagnosis of nephrotic syndrome (a kidney condition that causes large loss of protein in the urine).
  • Having severe kidney failure, known as severe renal insufficiency.
  • Having taken certain medicines or treatments within a restricted time period defined by the study protocol.
  • Having ongoing or long‑term liver or bile‑duct disease (hepatobiliary or hepatic disease).
  • Having poorly controlled Type 1 or Type 2 diabetes (blood‑sugar levels that are not kept within target ranges).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Sydvestjysk Sygehus Esbjerg Denmark
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Sanos A/S Gandrup Denmark
Zpkekdbybp Gucsxegb Vvsdbr Sxsurnibg Ede The Netherlands
Oywdvn Uxsdbbumve Hcjxefcp Odense Denmark
Acqwjfoci Ubf Amsterdam The Netherlands
Bxivga Zpadixgysu Roosendaal The Netherlands
Nsclavjwz Zelahgmpsjykrhd Slhufdwdt Alkmaar The Netherlands
Szdpebkjl Mfdscmi Zizmwitkze Groningen The Netherlands
Aelzrw Sftcxjwqro Zuuoynmdqp Dordrecht The Netherlands
D &gyji A Ruuatzcm Byde Sneek The Netherlands
Zaiklegukl Sv Jvfqfdk Harderwijk The Netherlands
Hmonuigo Vdas dpsppeym Barcelona Spain
Frhnodqynv Ghsw Offenbach Am Main Germany
Ikrrzytws Mxyadl Qswcmygnex Skj Rwqftu Sgtk A Coruna Galicia Spain
Uukdzcxooymxpicqzypev Eudmssjx Ane Erlangen Germany
Dfbwseovq Hqmvadtpfny Mtueuook Dri Fddzakrhygf Bexqza Kxslrn Ai Dkp Tagtzssgasf Uvibhyrdtfix Mpqjzpcv Munich Germany
Hpticuqd Cvsvvs Dq Beuucolyo Barcelona Spain
Cffmiax Uwuautbpmxbfbsdprfxv Bekrnu Kkt Berlin Germany
Upbllpdjuq Cctmdcfd Hssytcvt Vksueo Dl Li Aeticwxc Murcia Spain
Hhjocdph Uampnqyzopzhs Vanxer Dw Vvukt Sevilla Spain
Rnkswr Mjkabuycckh Aarhus Denmark
Kxodtcnb Kkohyznc Gofx Konstanz Germany
Fqtmebuph Plqv Lm Iniuwanqxklgb Bdqxsabbv Dba Hbyldkkj Umhlkellalqiq La Pjs Madrid Spain
zcus Zxxvjss flbj Ijkzdrbecnqbv Bvdofe Pdgdkhyazo Bcgy Gbko Berlin Germany
Bk Beddw Admhqtxqte Hbqsvxyjlax Kltwne Msz Gckw Kassel Germany
Scwwiiybcsmsor Bcrarwu Stuhr Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
31.08.2026
Germany Germany
Recruiting
31.08.2026
Spain Spain
Recruiting
31.08.2026
The Netherlands The Netherlands
Recruiting
31.08.2026

Trial locations

MK-7262 is an oral, film‑coated tablet that is being tested to see if it can lower the amount of “bad” cholesterol (LDL‑C) and a special protein called lipoprotein(a) that can increase heart risk. In the study, participants may take this medicine alone (monotherapy) or together with another drug. Researchers want to know how well it works by itself and whether it adds extra benefit when combined with the other medication.

MK-0616 (which contains the active ingredient enlicitide decanoate) is an oral tablet that is also being studied for its ability to reduce lipoprotein(a) and LDL‑C. In the trial, it may be given by itself or together with MK‑7262. The goal is to find out how much this medicine alone can lower the target cholesterol levels and how it works when added to the other drug.

Elevated lipoprotein(a) – Elevated lipoprotein(a) is a condition in which the blood contains higher than normal levels of the lipoprotein particle Lp(a). Lp(a) consists of an LDL‑like particle attached to a protein called apolipoprotein(a). Levels tend to remain stable over a person’s lifetime, and the concentration can increase modestly with age or certain hormonal changes. The condition may persist unless lifestyle or metabolic factors influence its level.

Trial ID:
2025-525102-38-00
Protocol code:
MK-7262-004
Trial Phase:
Therapeutic exploratory (Phase II)

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