Recruiting
A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
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).
ClinicalTrials.gov IDNCT07590193
PhasePHASE1
Enrollment162
SponsorAmgen
Age18 Years
SexALL
Conditions studied
Diabetes Mellitus, Type 2
About this study
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).
Interventions
- Drug: AMG 127 — AMG127 will be administered as either a SC injection or as an IV infusion.
- Drug: Placebo — Placebo will be administered as either a SC injection or as an IV infusion.
Primary outcomes
- 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))
Eligibility information
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
Study locations
- Orange County Research Center, Lake Forest, California 92630 United States
- Translational Clinical Research LLC, Aventura, Florida 33180 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.