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

Amgen

Status and phase: Terminated; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo; Drug: AMG 171

Study type: Interventional

Funder types: Industry

Identifiers

NCT04199351

20180224

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Males and females with ages between 18 and 65 years old, inclusive
• Except for obesity, otherwise healthy
• Body mass index (BMI) greater than or equal to 30.0 kg/m2 and less than or equal to 40.0 kg/m2 at screening
• Other Inclusion criteria may apply

Exclusion Criteria:

• Currently receiving treatment in another investigational device or drug study
• Women of childbearing potential
• History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
• Other Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Part A

Experimental group

Description:

AMG 171 or placebo, 2 SAD cohorts

Treatment:

Drug: Placebo

Drug: AMG 171

Part B

Experimental group

Description:

AMG 171 or placebo, 1 MAD cohort

Treatment:

Drug: Placebo

Drug: AMG 171

Part C

Experimental group

Description:

AMG 171 or placebo, 3 titration cohorts

Treatment:

Drug: Placebo

Drug: AMG 171