AMG 127: AMG127 will be administered as either a SC injection or as an IV infusion.
Placebo: Placebo will be administered as either a SC injection or as an IV infusion.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Number of Treatment-Emergent Adverse Events (TEAEs) — Part A, SAD: Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Day 1 to end of trial (up to approximately 87 days)
Number of Serious Adverse Events (SAEs) — Part A, SAD: Screening to end of trial (up to approximately 86 days); Part B, MAD: Screening to end of trial (up to approximately 114 days); Part C, PoM: Screening to end of trial (up to approximately 115 days)
Number of Adverse Events Leading to Study Discontinuation — Part A, SAD: Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Day 1 to end of trial (up to approximately 87 days)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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