A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Phase 1
Phase 2
Interventional Study
Healthy Volunteers
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 172 (estimated)
- Sponsor
- Regeneron Pharmaceuticals · Industry
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About This Trial
This study is researching an experimental drug called ALN-PNP (called "study drug"). This is a first in human study. The study drug is not approved by any public health agency such as the United States Food and Drug Administration (FDA) for any kind of treatment.
This study consists of 3 parts. Part A is focused on healthy participants. Parts B and C of the study are focused on participants who a…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
Part A (Healthy Adults):
1. From 18 to 55 years of age
2. For Japanese cohorts ONLY; the Japanese participant must:
1. Be Japanese, born in Japan, and have both biologic parents and 4 biologic grandparents who are ethnically Japanese and born in Japan
2. Have maintai…
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