AMG-513 / Amgen - LARVOL DELTA

FDA frees Amgen's phase 1 obesity asset from clinical trial hold (FierceBiotech) - "The FDA has freed Amgen’s mysterious early-stage obesity asset from a clinical hold, with the phase 1 study now enrolling participants...The historically tight-lipped Amgen execs remain judicious with what they share, providing few details regarding the matter on a May 1 earnings call....The obesity asset is being tested in a placebo-controlled, single and multiple ascending dose trial that launched in September 2024, according to ClinicalTrials.gov. The trial is expected to enroll about 80 participants with obesity, with a primary readout slated for mid-2026."

P1 data • Trial status • Obesity

Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Amgen | Active, not recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Metabolic Disorders • Obesity

Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: Amgen | Suspended ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Metabolic Disorders • Obesity

Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity (clinicaltrials.gov) - P1 | N=80 | Suspended | Sponsor: Amgen | Recruiting ➔ Suspended

Trial suspension • Genetic Disorders • Metabolic Disorders • Obesity

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS (PRNewswire) - "MariTide (maridebart cafraglutide, AMG 133): Part 2 of the Phase 2 chronic weight management study is ongoing in adults who are living with overweight or obesity, with or without Type 2 diabetes mellitus. Data readout is anticipated in H2 2025. A Phase 2 study investigating MariTide for the treatment of Type 2 diabetes mellitus is enrolling adults living with and without obesity. Data readout is anticipated in H2 2025. Planning for MARITIME, a broad Phase 3 program across multiple indications remains on track with the first studies expected to begin in H1 2025....AMG 513: A Phase 1 study of AMG 513 in people living with obesity was placed on clinical hold by the U.S. Food and Drug Administration (FDA)."

New P3 trial • P2 data • Trial suspension • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Amgen | Trial completion date: Mar 2026 ➔ Aug 2026 | Trial primary completion date: Mar 2026 ➔ Aug 2026

Trial completion date • Trial primary completion date • Genetic Disorders • Metabolic Disorders • Obesity

Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Metabolic Disorders • Obesity

Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Amgen

New P1 trial • Genetic Disorders • Metabolic Disorders • Obesity