Enlicitide + Lithium for Healthy Subjects

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Lithium

Disqualifiers: Cancer, Psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how enlicitide, a new medicine, interacts with lithium, a common treatment for bipolar disorder. Researchers seek to determine if the blood levels of lithium change when taken with enlicitide compared to lithium alone. They also aim to assess the safety and tolerance of lithium both with and without enlicitide. The trial seeks participants who are generally healthy, do not smoke, and have no significant medical history. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves taking lithium, it might be best to discuss your current medications with the trial team to ensure there are no interactions.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that enlicitide is as safe as a placebo, meaning it doesn't cause more side effects than a sugar pill. Participants in previous studies followed the instructions well, indicating ease of management.

Lithium is a common treatment for bipolar disorder. This trial will test whether the body processes lithium the same way when taken with enlicitide and will check for any new side effects from using them together.

As a Phase 1 study, the focus is on safety and treatment tolerance. This phase typically involves a small group of healthy participants to ensure safety before progressing to larger studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the enlicitide and lithium combination because it offers a new approach to mood stabilization. Unlike traditional treatments that focus solely on lithium’s mood-stabilizing properties, enlicitide introduces a new peptide-based mechanism that may enhance lithium's effects or reduce its side effects. This could potentially lead to more effective and faster-acting mood stabilization with fewer adverse effects, making it a promising option for individuals seeking improved treatment outcomes.

What evidence suggests that enlicitide with lithium could be effective for lowering LDL-C?

Research has shown that enlicitide produces promising results in lowering LDL cholesterol, often known as "bad" cholesterol. One study found that enlicitide reduced LDL cholesterol by up to 60%, suggesting it could be a good option for people needing to lower their cholesterol levels. Additionally, enlicitide reduced another type of cholesterol, non-HDL-C, by 53.4%. In this trial, one group of participants will receive lithium alone, while another group will receive a combination of enlicitide and lithium. The study aims to assess how these two drugs work together in the body. While enlicitide’s ability to lower cholesterol is clear, the study will also evaluate its safety and tolerability when used with lithium. ^{1 2 3 4 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for healthy adults with no significant medical history, who haven't smoked or used nicotine/tobacco products in the last 3 months. It's designed to see how a new cholesterol-lowering medicine, enlicitide, interacts with lithium.

Inclusion Criteria

I haven't smoked or used nicotine products for at least 3 months.

I am generally healthy with no major medical issues.

Exclusion Criteria

I have a significant health or mental health condition.

I have had cancer in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Period 1

Participants receive a single oral dose of lithium carbonate

1 day

1 visit (in-person)

Treatment Period 2

Participants receive a single oral dose of lithium carbonate coadministered with enlicitide

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enlicitide
• Lithium

Trial Overview The study is testing the effects of taking enlicitide and lithium carbonate together. Researchers will measure blood levels of lithium when taken alone versus alongside enlicitide to assess any differences and overall safety.

How Is the Trial Designed?

Group I: Lithium Carbonate Experimental Treatment 1 Intervention

On Day 1 of Period 1, a single oral dose of lithium carbonate will be administered.

Group II: Enlicitide with Lithium Carbonate Experimental Treatment 2 Interventions

On Day 1 of Period 2, a single oral dose of lithium carbonate will be coadministered with a single oral dose of enlicitide.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. merck.com merck.com/news/mercks-enlicitide-decanoate-an-investigational-oral-pcsk9-inhibitor-significantly-reduced-ldl-c-in-phase-3-coralreef-lipids-trial/

Merck's Enlicitide Decanoate, an Investigational Oral ... At week 24, enlicitide demonstrated reductions in non-HDL-C of 53.4% (95% CI: -55.5, -51.2; p<0.001), ApoB of 50.3% (95% CI: -52.1, -48.5; p< ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06719544

NCT06719544 | A Study of Lithium and Enlicitide in ... Learn about the safety of lithium when taken alone or with enlicitide and if people tolerate it.

3. withpower.com withpower.com/trial/enlicitide-lithium-for-healthy-subjects-4deec

Enlicitide + Lithium for Healthy Subjects · Info for Participants Trial Overview The study is testing the effects of taking enlicitide and lithium carbonate together. Researchers will measure blood levels of lithium when taken ...

4. trial.medpath.com trial.medpath.com/clinical-trial/a3cf79079566e0db/clinical-study-enlicitide-lithium-pharmacokinetics

A Study of Lithium and Enlicitide in Healthy Adult Participants ... Researchers have designed a new study medicine called enlicitide decanoate (MK-0616) as a new way to lower the amount of low-density lipoprotein cholesterol ...

5. newsroom.heart.org newsroom.heart.org/news/investigational-daily-pill-lowered-bad-cholesterol-as-much-as-injectables

Investigational daily pill lowered bad cholesterol as much ... The oral medication, enlicitide, lowered LDL cholesterol by up to 60% and could eventually offer an option for people whose LDL levels remain ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06719544?term=AREA%5BInterventionSearch%5D(LITHOBID)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=8

A Study of Lithium and Enlicitide in Healthy Adult ... A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...