Amgen Terminates Early-Stage AMG 378 Study: What Investors Should Watch Next

Amgen Inc (AMGN) announced an update on their ongoing clinical study.

The Phase 1 study “A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose and Food-effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics of AMG 378 in Healthy Participants” was designed to test Amgen’s new oral drug AMG 378 in healthy adults. It aimed to understand basic safety, how the drug moves through the body, and any effect of food, an early but important step in future development plans.

The trial tested AMG 378 as an oral tablet versus placebo in several dosing parts. Single and multiple dose schedules were used to see how people tolerate increasing exposure, while a food-effect arm checked how a high-fat meal changes drug levels, which can later guide dosing guidance and real-world use.

The design was interventional, randomized, and double blind, meaning participants and study doctors did not know who received AMG 378 or placebo. Doses were given in sequence across groups, with a cross-over setup in the food-effect cohort, so the primary goal was basic science rather than direct treatment benefit at this stage.

The study was sponsored by Amgen Inc. and registered as NCT06910709, with healthy volunteers as the only condition. The overall status is listed as terminated, indicating dosing stopped earlier than planned, and no results have yet been posted, which limits insight into the specific reasons or data trends behind the decision.

Key timeline points show the study was first submitted on March 28, 2025, signaling the formal launch of the program. The record was last updated on March 31, 2026, which is relevant for investors since it confirms the termination status is recent and reflects Amgen’s latest position on AMG 378.

For investors, early termination in a Phase 1 healthy volunteer study often raises questions about safety signals, strategic reprioritization, or weaker-than-expected data. While Phase 1 assets rarely drive near-term revenue for a large firm like Amgen (AMGN), such updates can affect pipeline confidence, especially when compared with peers whose early-stage programs are advancing as planned.

In the short term, the impact on AMGN’s stock is likely modest, but sentiment around Amgen’s internal R&D productivity may soften at the margin. The broader large-cap biotech group has multiple early-stage bets, so investors may discount a single terminated study, yet they will watch future disclosures for clarity on whether this reflects a narrow setback or a broader shift in portfolio focus.

This study is now listed as terminated and its record recently updated, with additional information and any future changes available on the ClinicalTrials.gov portal.

To learn more about AMGN’s potential, visit the Amgen Inc drug pipeline page.