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
Overview
- Phase
- Phase 1
- Intervention
- AMG 171
- Conditions
- Obesity
- Sponsor
- Amgen
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
To assess the safety and tolerability of AMG 171 as single or multiple doses in subjects with obesity
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Arms & Interventions
Part A
AMG 171 or placebo, 2 SAD cohorts
Intervention: AMG 171
Part A
AMG 171 or placebo, 2 SAD cohorts
Intervention: Placebo
Part B
AMG 171 or placebo, 1 MAD cohort
Intervention: AMG 171
Part B
AMG 171 or placebo, 1 MAD cohort
Intervention: Placebo
Part C
AMG 171 or placebo, 3 titration cohorts
Intervention: AMG 171
Part C
AMG 171 or placebo, 3 titration cohorts
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From first dose of IP to end of study, up to Day 207
An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with study treatment. A serious AE (SAE) was an AE meeting at least 1 of the following serious criteria: fatal, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability; congenital anomaly/birth defect; other medically important serious event. Clinically significant changes from baseline in laboratory safety tests, vital sign assessments, and 12-lead electrocardiogram assessments were included as TEAEs.
Secondary Outcomes
- Maximum Observed Serum Concentration (Cmax) for AMG 171: SAD Cohorts 1 and 1b(Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120)
- Cmax for AMG 171: MAD Cohorts 2 - 5(Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85)
- Time of Cmax (Tmax) for AMG 171: SAD Cohorts 1 and 1b(Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120)
- Tmax for AMG 171: MAD Cohorts 2 - 5(Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85)
- Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) for AMG 171: SAD Cohorts 1 and 1b(Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120)
- AUC From Time 0 to 14 Days (AUC0-14) for AMG 171: MAD Cohorts 2 - 4(Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113)
- AUC From Time 0 to 7 Days (AUC0-7) for AMG 171: MAD Cohort 5(Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85)
- Number of Participants With Anti-AMG 171 Antibodies(Cohorts 1 and 1b: Day 1 pre-dose, Days 15, 29, 120; Cohort 2: Days 1, 29, 57 pre-dose, Days 15, 85, 207; Cohort 3: Days 1, 15 pre-dose, Days 29, 57, 85; Cohort 4: Days 1, 15, 29 pre-dose, Days 43, 85, 113; Cohort 5: Days 1, 8 pre-dose, Days 29, 57, 85)