Amgen Advances Early-Stage Obesity Candidate With New Injection Trial

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

Amgen Tests New Obesity Drug Delivery in Early-Stage Trial

Study Overview: Amgen is running a Phase 1 trial to see how its obesity drug candidate, maridebart cafraglutide (AMG 133), behaves in the body when given in two different under-the-skin formats. Officially titled “A Phase 1, Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations in Participants Living With Overweight or Obesity,” the study focuses on how much of the drug is absorbed and how long it stays in the bloodstream. For investors, this is an early but important step in confirming that Amgen can deliver this potential obesity treatment in a user-friendly way that supports later-stage trials and, eventually, commercial use.

Intervention/Treatment: The study tests maridebart cafraglutide, an injectable drug given under the skin (subcutaneous). Participants receive a single dose of the same drug in one of two injection formats, or “presentations.” The goal is not to compare the drug against a placebo, but to see which injection format delivers the drug more efficiently and consistently, helping Amgen optimize how the product could be offered to patients if approved.

Study Design: This is an interventional study in which participants are randomly assigned to one of two groups. Each group receives a single dose of maridebart cafraglutide using one of the two injection presentations. The design is “parallel,” meaning each participant stays in their assigned group without switching. The trial is “open-label,” so both researchers and participants know which presentation is being used. The main purpose is treatment-focused: to refine how the drug is delivered in people who are overweight or have obesity, and to collect data that can support dosing and device decisions in future trials.

Study Timeline: The trial is currently listed as recruiting, indicating that enrollment is still underway. The study was first submitted on December 19, 2025, marking the formal regulatory filing date and signaling the start of the study process. The most recent update was submitted on January 5, 2026, which shows the record has been reviewed and refreshed, often a sign of protocol clarifications or operational progress. Primary and final completion dates are not explicitly stated here, but given the Phase 1 nature, investors can assume a relatively short duration compared with later-stage outcome studies, with data that may emerge within a typical 12–24 month early-phase window.

Market Implications: This update reinforces Amgen’s push into the high-growth obesity drug market, currently dominated by GLP-1–based products from Novo Nordisk and Eli Lilly. While this trial is small and early-stage, success in comparing these two injection presentations could make future development smoother, support better patient adherence, and help Amgen position maridebart cafraglutide as a competitive, convenient option. For AMGN shares, steady progress in obesity is supportive for long-term valuation and can improve sentiment around Amgen’s growth pipeline, even if near-term stock moves may be modest given the early phase. Investors should watch for upcoming Phase 2 and Phase 3 plans, where efficacy and safety data versus competitors will become central to the investment case.

The study remains active and recruiting, with current details and any future changes available on the ClinicalTrials.gov portal.

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