A Phase 1, Randomized, Double Blind, Multiple Dose, Placebo-controlled, Parallel Group Study to Evaluate the Impact of AMG 133 on Gastric Emptying in Participants Living With Overweight or Obesity

Registration

Registration

NCT07429032

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

COMPLETED

Enrollment

57

Start

2025-04-17

Primary completion

2025-11-26

Lead sponsor

Amgen

Conditions

Overweight or Obesity

Interventions

DRUG:AMG 133; DRUG:Placebo; DRUG:Acetaminophen

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Maximum Observed Plasma Concentration (Cmax) for Acetaminophen [Days 1, 3, 8, 17, 31, 59, 64, and 86]
• Time to Cmax (Tmax) for Acetaminophen [Days 1, 3, 8, 17, 31, 59, 64, and 86]
• Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) for Acetaminophen [Days 1, 3, 8, 17, 31, 59, 64, and 86]
• AUC from Time Zero to Infinity (AUCinf) for Acetaminophen [Days 1, 3, 8, 17, 31, 59, 64, and 86]
• AUC from Time Zero to 5 Hours (AUC5hr) for Acetaminophen [Days 1, 3, 8, 17, 31, 59, 64, and 86]