NCT04199351

Single and Multiple Ascending Dose Study of AMG 171 in Subjects With Obesity

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 171 in Subjects With Obesity

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and tolerability of AMG 171 as single or multiple doses in subjects with obesity

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	AMG 171	2 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A; 1 cohort of 8 subjects 3:1 ratio in Part B; and 24 subjects enrolled into 1 of 3 cohorts with 8 subjects randomized to receive 2 to 3 consecutive doses (titration) 3:1 ratio in Part C.
DRUG	Placebo	AMG 171 placebo

Timeline

• Start date: 2019-12-13
• Primary completion: 2021-09-10
• Completion: 2021-09-10
• First posted: 2019-12-13
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study