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Ulonivirine with Atorvastatin and Metformin for Healthy Adults

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Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Atorvastatin, Metformin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a new treatment, ulonivirine, affects the levels of two common medications, atorvastatin and metformin, in the body. Researchers aim to determine if any differences occur when these medications are taken with ulonivirine compared to without it. The trial seeks healthy adults with a body mass index (BMI) between 18 and 32 and no significant health issues. As a Phase 1 trial, the research focuses on understanding how ulonivirine works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves atorvastatin and metformin, you might need to discuss with the trial team if you are already taking these or other medications.

Is there any evidence suggesting that ulonivirine is likely to be safe for humans?

Research has shown that ulonivirine has generally been well-tolerated in past studies. Safety data indicate that when combined with another drug, islatravir, the side effects resemble those of an existing treatment called Biktarvy. This similarity suggests that ulonivirine might be as safe as some already approved treatments. However, some participants stopped using it due to side effects. Overall, the evidence supports further research into its safety.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about ulonivirine because it introduces a novel approach to managing metabolic conditions when combined with atorvastatin and metformin. While traditional treatments like atorvastatin and metformin target cholesterol levels and blood sugar control, ulonivirine may offer additional benefits by potentially enhancing metabolic regulation in a new way. This combination might optimize the effects of standard treatments, possibly leading to more effective management of metabolic health in healthy adults. The unique mechanism of ulonivirine could complement existing therapies, sparking hope for improved outcomes and new insights into metabolic health management.

What evidence suggests that ulonivirine might be an effective treatment when combined with atorvastatin and metformin?

Research has shown that taking atorvastatin and metformin together can significantly lower bad cholesterol (LDL-C) and improve blood sugar levels. One study found that this combination reduced LDL-C levels by more than 55%, compared to just under 8% with metformin alone. It also helped reduce total cholesterol, triglycerides (a type of fat in the blood), and fasting blood sugar, while increasing good cholesterol (HDL). In this trial, researchers are investigating how ulonivirine might work with atorvastatin and metformin. Although specific data on ulonivirine's effectiveness in this combination is not yet available, the hypothesis is that ulonivirine might alter how the body processes these drugs, potentially enhancing their benefits.678910

Who Is on the Research Team?

MD

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 issues, normal lab results and heart tests, and a BMI between 18.0 and 32.0.

Inclusion Criteria

I am medically healthy with no significant health issues or abnormal test results.
* Has body mass index (BMI) 18.0 and ≤ 32.0 kg/m\^2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Period 1

Participants receive atorvastatin and metformin

1 day
1 visit (in-person)

Treatment Period 2

Participants receive atorvastatin, metformin, and ulonivirine

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 21 days

What Are the Treatments Tested in This Trial?

Interventions

  • Ulonivirine

Trial Overview

The study looks at how the body processes atorvastatin and metformin when taken alone or together with ulonivirine. Participants receive these medications in different combinations to compare their effects.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Atorvastatin + metformin + ulonivirineExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin ...

Researchers want to learn about ulonivirine when given with atorvastatin and metformin in healthy people. The goal of this study is to compare the amount of ...

Ulonivirine with Atorvastatin and Metformin for Healthy Adults

Researchers want to learn about ulonivirine when given with atorvastatin and metformin in healthy people. The goal of this study is to compare the amount of ...

A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin ...

Researchers want to learn about ulonivirine when given with atorvastatin and metformin in healthy people. The goal of this study is to compare the amount of ...

Efficacy and Safety of Metformin and Atorvastatin Combination ...

The combination group also showed a significant decrease in LDL-C levels compared to the metformin group (−55.20% vs. −7.69%, P<0.001) without previously ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38763510/

Efficacy and Safety of Metformin and Atorvastatin ...

Conclusion: The addition of atorvastatin to metformin improved HbA1c and LDL-C levels to a significant extent compared to metformin or ...

Material Safety Data Sheet of Ulonivirine

Use full personal protective equipment. Avoid breathing vapors, mist, dust or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Refer to ...

Ulonivirine Health Professional Drug Record | NIH

Available safety data showed that islatravir plus ulonivirine had a comparable AE profile to that of Biktarvy. Three participants discontinued islatravir plus ...

Study Details | NCT02174159 | Evaluation of Safety, ...

The hypothesis tested in the study is that at a safe and well-tolerated dose, ulonivirine has superior antiretroviral activity to a historical placebo control, ...

Ulonivirine (MK-8507) - LAPaL - Medicines Patent Pool

The pharmacokinetics and safety data are supportive of once-weekly oral administration and support further clinical investigation of MK-8507 for the treatment ...

Ulonivirine | CAS# 1591823-76-5 | HIV-1 NNRTI

Shipped under ambient temperature as non-hazardous chemical. This product is stable enough for a few weeks during ordinary shipping and time spent in Customs.