A Phase 1, First-in-human Study of MORF-440 (LY4292009) in Healthy Participants

Launched by MORPHIC HOLDINGS, INC, A WHOLLY OWNED SUBSIDIARY OF ELI LILLY AND COMPANY · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called MORF-440 to see if it is safe for healthy people. The main goal is to check how well the drug is tolerated when given in increasing doses. This means that participants will receive different amounts of the drug to help researchers understand its effects. The trial is currently looking for healthy adults aged between 18 and 65 years, with a body mass index (BMI) between 18.0 and 30.0. Additionally, participants must agree to use contraception if they are capable of becoming pregnant or fathering a child.

If you choose to participate, you will receive the drug under close medical supervision, and your health will be monitored throughout the study. It's important to note that participants should not be pregnant, breastfeeding, or using nicotine products during the study. This trial is an early step in understanding how safe MORF-440 is, which could help in developing treatments for future medical conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Body mass index (BMI) within 18.0 kg/m² to 30.0 kg/m², inclusive
• * If male, meets one of the following:
• • can procreate and agree to use one of the accepted to use one of the accepted contraceptive regimens and not to donate sperm from the first study drug administration to at least 90 days after the last drug administration.
• • is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 180 days prior to the first study drug administration)
• * if female, meets one of the following:
• • is of childbearing potential and agrees to use an acceptable contraceptive method.
• * is of non-childbearing potential, defined as either:
• • Surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or
• * is in a postmenopausal state:
• • At least 1 year without menses and without an alternative medical condition prior to the screening, and follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at screening or at least 1 year without menses and without an alternative medical condition prior to the screening, follicle stimulating hormone FSH levels \< 40 milli-international units per milliliter (mIU/mL) and estradiol serum level ≤150 picomole/Liter (pmol/L) at screening
• Exclusion Criteria:
• • Female who is lactating or who is pregnant according to the pregnancy test at screening or prior to the first study drug administration, or planning to become pregnant during the study period up to 30 days after the last study drug administration
• • 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