A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAmgen
About this trial
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
This trial accepts healthy volunteersQualifiers
Participant must be 18-65 years of age
Participant must be overtly healthy
Participant must be 40-75 years of age
Confirmed diagnoses of T2DM
Disqualifiers
History of hypotension, syncope, or orthostatic intolerance
Systolic blood pressure >140 millimeters of mercury (mmHg) or diastolic blood pressure >90 mmHg
Hemoglobin A1c (HbA1c) >10% within the last 3 months
History of hypotension, syncope, or orthostatic intolerance
Trial design
Design model
Parallel
Treatments tested in this trial
AMG 127
DrugAMG127 will be administered as either a SC injection or as an IV infusion.
Placebo
DrugPlacebo will be administered as either a SC injection or as an IV infusion.
Treatment groups
162 Participants
are divided into 4 treatment groupsGroup A: Part A: Single Ascending Dose (SAD)Experimental treatment 1 intervention
Group B: Part B: Multiple Ascending Dose (MAD)Experimental treatment 1 intervention
Group C: Part C: Proof of Mechanism (PoM)Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Treatment-Emergent Adverse Events (TEAEs)
Time frame
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)2
Number of Serious Adverse Events (SAEs)
Time frame
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)3
Number of Adverse Events Leading to Study Discontinuation
Time frame
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)Secondary outcomes
1
Maximum Concentration (Cmax) of AMG 127
Time frame
Part A, SAD: Predose on Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Predose on Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Predose on Day 1 to end of trial (up to approximately 87 days)2
Area Under the Curve (AUC) of AMG 127
Time frame
Part A, SAD: Predose on Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Predose on Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Predose on Day 1 to end of trial (up to approximately 87 days)3
Incidence and Severity of Retinal Structural Abnormalities Assessed by Optical Coherence Tomography (OCT) in Participants With Type 2 Diabetes Mellitus
Time frame
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) Source ClinicalTrials.gov