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NCT07590193
A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
Conditions: Diabetes Mellitus, Type 2
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 162
Sponsor: Amgen
Location: Translational Clinical Research LLC Aventura Florida
Summary
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).
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07590193). StuddyBuddy aggregates publicly available trial information.