A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

Purpose

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).

Condition

  • Diabetes Mellitus, Type 2

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: Single Ascending Dose (SAD) 		Participants will receive single ascending doses of AMG 127 via subcutaneous (SC) injection. One cohort will receive a single dose of AMG 127 as an intravenous (IV) infusion.
  • Drug: AMG 127
    AMG127 will be administered as either a SC injection or as an IV infusion.
Experimental
Part B: Multiple Ascending Dose (MAD) 		Participants will receive multiple ascending doses of AMG 127 via SC injection.
  • Drug: AMG 127
    AMG127 will be administered as either a SC injection or as an IV infusion.
Experimental
Part C: Proof of Mechanism (PoM) 		Participants will receive multiple doses of AMG 127 via SC injection.
  • Drug: AMG 127
    AMG127 will be administered as either a SC injection or as an IV infusion.
Placebo Comparator
Placebo 		Participants will receive a matching placebo 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.

Recruiting Locations

Translational Clinical Research LLC
Aventura, Florida 33180

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com