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

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

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Drug: AMG 171
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>AMG 171 or placebo, 2 SAD cohorts | Drug: AMG 171<br>* 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.<br>Drug: Placebo<br>* AMG 171 placebo<br>|
| Experimental: Part B<br>AMG 171 or placebo, 1 MAD cohort | Drug: AMG 171<br>* 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.<br>Drug: Placebo<br>* AMG 171 placebo<br>|
| Experimental: Part C<br>AMG 171 or placebo, 3 titration cohorts | Drug: AMG 171<br>* 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.<br>Drug: Placebo<br>* AMG 171 placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject incidence of treatment-emergent adverse events. |  | through study completion, up to day 207 | 
| Subject incidence of clinically significant changes in laboratory safety test results |  | through study completion, up to day 207 | 
| Subject incidence of clinically significant changes in vital sign assessments |  | through study completion, up to day 207 | 
| Subject incidence of clinically significant changes in 12-lead electrocardiogram (ECG) assessments |  | through study completion, up to day 207 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter - maximum plasma concentration (Cmax) |  | through study completion, up to day 207 | 
| Pharmacokinetic parameter - time to maximum plasma concentration (Tmax) |  | through study completion, up to day 207 | 
| Pharmacokinetic parameter - area under the plasma concentration-time curve (AUC) |  | through study completion, up to day 207 | 
| Incidence of anti-AMG 171 antibody formation |  | through study completion, up to day 207 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity