Testing the safety of MORF-440 in healthy participants

A Phase 1, First-in-human Study of MORF-440 in Healthy Participants, Including Single and Multiple Ascending Dose Cohorts

This study is testing the safety of a new drug called MORF-440 in healthy people to see how well they can tolerate it at different doses.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Eli Lilly and Company (industry)
• Locations: 1 site (Mont-royal, Quebec)
• Trial ID: NCT06977880 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of MORF-440 (LY4292009) through single ascending doses administered to healthy participants. It includes a single-ascending dose (SAD) and a maximum ascending dose (MAD) substudy to assess how the drug is tolerated at increasing doses. The study aims to gather important data on the drug's effects in a controlled environment. Participants will receive either the drug or a placebo to determine its safety profile.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 65 with a BMI between 18.0 and 30.0 kg/m².

Not a fit: Patients with significant health issues or those outside the specified BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable safety data that may lead to future therapeutic applications of MORF-440.

How similar studies have performed: Other first-in-human studies have shown success in establishing safety profiles for new drugs, making this approach a standard practice in clinical research.

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

Where this trial is running

Mont-royal, Quebec

• Altasciences Company Inc. — Mont-royal, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Conditions: Healthy