A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
Recruiting · NCT07590193 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
AMG 127Placebo
What this trial is about
The main objective of this trial is to assess the safety and tolerability of AMG 127 as single dose and multiple doses in healthy participants and participants with type 2 diabetes mellitus (T2DM).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- for Part A and B
- Participant must be 18-65 years of age
- Participant must be overtly healthy
- Inclusion Criteria for Part C
- Participant must be 40-75 years of age
- Confirmed diagnoses of T2DM
Exclusion criteria
- for Part A and B
- History of hypotension, syncope, or orthostatic intolerance
- Systolic blood pressure \>140 millimeters of mercury (mmHg) or diastolic blood pressure \>90 mmHg
- Exclusion Criteria for Part C
- Hemoglobin A1c (HbA1c) \>10% within the last 3 months
- History of hypotension, syncope, or orthostatic intolerance
- Systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg
Where it is running
2 locations listed across 2 US states.
- Orange County Research Center - Lake Forest, California, United States
- Translational Clinical Research LLC - Aventura, Florida, United States