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Recruiting
Sponsor ID
20250058

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

Sponsor ID
20250058
Clinicaltrials.gov ID
NCT07590193
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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).

Additional Study Details

Phase
Phase 1
Product
AMG 127
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
162
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Treatment‑Emergent Adverse Events (TEAEs)

Timeframe: 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)

Timeframe: 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

Timeframe: 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 Outcome Measures

Maximum Concentration (Cmax) of AMG 127

Timeframe: 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)

Area Under the Curve (AUC) of AMG 127

Timeframe: 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)

Severity of Retinal Structural Abnormalities Assessed by Optical Coherence Tomography (OCT) in Participants With Type 2 Diabetes Mellitus

Timeframe: 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)

Locations

Location
Status
Contact Us
Location
Translational Clinical Research LLC
Aventura, FL, United States, 33180
Status
Recruiting
Location
Orange County Research Center
Lake Forest, CA, United States, 92630
Status
Recruiting
Study Info
Age
18 - 75 Years
Condition
  • Diabetes
    • Sex
    All
    Trial Dates
    Jun 2026 - Oct 2027
    Inclusion and Exclusion 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