AMG 786 for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Translational Clinical Research LLC, Aventura, FL
Obesity
AMG 786 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary objective of this study is to assess the safety and tolerability of AMG 786 as single or multiple doses in healthy and obese participants.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Day 1 through end of study (approximately 40 days)

Day 40
AUC of Metabolite M5
Area Under the Concentration-time Curve (AUC) of AMG 786
Cmax of Metabolite M5
Maximum Observed Concentration (Cmax) of AMG 786
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Time of Maximum Observed Concentration (Tmax) of AMG 786
Tmax of Metabolite M5

Trial Safety

Trial Design

3 Treatment Groups

Part A: Food Effect Cohort
1 of 3
Part B: Multiple Ascending Dose Cohorts
1 of 3
Part A: Single Ascending Dose Cohorts
1 of 3
Experimental Treatment

78 Total Participants · 3 Treatment Groups

Primary Treatment: AMG 786 · Has Placebo Group · Phase 1

Part A: Food Effect CohortExperimental Group · 2 Interventions: Placebo, AMG 786 · Intervention Types: Other, Drug
Part B: Multiple Ascending Dose CohortsExperimental Group · 2 Interventions: Placebo, AMG 786 · Intervention Types: Other, Drug
Part A: Single Ascending Dose CohortsExperimental Group · 2 Interventions: Placebo, AMG 786 · Intervention Types: Other, Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 through end of study (approximately 40 days)
Closest Location: Translational Clinical Research LLC · Aventura, FL
Photo of florida 1Photo of florida 2Photo of florida 3
2021First Recorded Clinical Trial
1 TrialsResearching Obesity
1 CompletedClinical Trials

Who is running the clinical trial?

AmgenLead Sponsor
1,279 Previous Clinical Trials
1,300,565 Total Patients Enrolled
6 Trials studying Obesity
383 Patients Enrolled for Obesity
MDStudy DirectorAmgen
824 Previous Clinical Trials
870,147 Total Patients Enrolled
3 Trials studying Obesity
220 Patients Enrolled for Obesity

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have provided informed consent/assent prior to study-specific activities/procedures.
You are female and not of childbearing potential.
You have a body mass index of at least 25 kg/m^2 and between 18 and 32.0 kg/m^2 for otherwise healthy participants with obesity.
You are willing to maintain your current general diet and physical activity regimen, except for the physical activity in the 72 hours before each blood sample collection for the clinical laboratory analysis, which should not be strenuous.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.