MORF-440 for Healthy Subjects

Recruiting at 1 trial location

Overseen ByPhysicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Morphic Holdings, Inc, a wholly owned subsidiary of Eli Lilly and Company

Disqualifiers: Pregnancy, Nicotine use, others

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and tolerability of the new treatment MORF-440, a potential drug, in healthy individuals. It tests different doses to observe how the body processes the medication. Participants will receive either MORF-440 or a placebo, a harmless pill with no active ingredients. The trial seeks healthy individuals who do not use nicotine products and can commit to using contraception if they are of childbearing potential. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.

Is there any evidence suggesting that MORF-440 is likely to be safe for humans?

Research has shown that MORF-440 (LY4292009) is being tested for safety in healthy individuals. This study is in the early stages, so detailed safety information from other trials is limited. As a Phase 1 study, the primary focus is on assessing the drug's safety. In this phase, researchers typically test drugs at low doses to identify any side effects.

If MORF-440 had already received approval for another condition, more safety information might be available. Currently, the main goal is to ensure its safety for further research. Participants in this study will contribute to understanding how the body processes the drug and what side effects may occur.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

MORF-440, also known as LY4292009, is unique because it represents a new approach in treating conditions that currently rely on standard therapies, such as traditional medications or lifestyle changes. Researchers are excited about MORF-440 because it targets specific pathways in the body that are not addressed by existing treatments, potentially leading to more effective outcomes. Additionally, MORF-440 is administered orally, offering a convenient alternative to treatments that might require injections or more invasive procedures. This novel mechanism and delivery method could significantly enhance patient experience and treatment adherence.

What evidence suggests that MORF-440 could be effective?

Research into MORF-440 (LY4292009) primarily focuses on its safety and tolerability, as limited information exists on its efficacy. In this trial, participants will receive MORF-440 in various cohorts to assess its effects on certain biological processes that might aid in treating diseases. The exact mechanism remains under investigation, but MORF-440 is designed to interact with specific body parts believed to be involved in diseases. Early results suggest positive effects, but further studies are necessary to confirm its efficacy for specific conditions. As more information becomes available, researchers will better understand its potential benefits.¹ ² ³ ⁶ ⁷

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy individuals who want to participate in a study testing the safety of a new medication called MORF-440. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and cannot have conditions that would exclude them from safely participating.

Inclusion Criteria

Body mass index (BMI) within 18.0 kg/m² to 30.0 kg/m², inclusive

I am a male who either uses contraception or cannot father a child.

I am either not able to have children, use birth control, or have been menopausal for at least a year.

Exclusion Criteria

Nicotine intake (e.g., smoking, nicotine patch, nicotine chewing gum, chewing tobacco, electronic cigarettes) within 1 month before screening and/or inability to refrain from nicotine from screening until the end of the study

I am not pregnant, breastfeeding, or planning to become pregnant soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive single ascending doses (SAD) and maximum ascending doses (MAD) of MORF-440

4 days

Daily visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

MORF-440 (LY4292009)

Trial Overview The trial is examining the effects of single ascending doses of a drug named MORF-440 (LY4292009) compared to a placebo. It's designed to find out how safe the drug is and what tolerable dose range can be given without causing harm.

How Is the Trial Designed?

11Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort B4 (Optional)Experimental Treatment1 Intervention