AMG 127 in healthy adults and adults with type 2 diabetes
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
Run by Amgen · NCT07590193 · Data updated 2026-11-12
This study tests whether a single dose or multiple doses of AMG 127 are safe and tolerable in healthy adults and adults with type 2 diabetes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 162 (estimated) |
| Sponsor | Amgen Industry-sponsored |
| Locations | 2 sites (Lake Forest, California and 1 other locations) |
| Status | Recruiting |
| Started | June 11, 2026 |
| Main results expected | October 2, 2027 |
| Study ends | October 2, 2027 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07590193 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 who are healthy for Parts A and B, or adults 40–75 with diagnosed type 2 diabetes for Part C.
✕Probably not a fit
Participants with uncontrolled hypertension or poorly controlled diabetes may not benefit and could be disqualified.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase interventional trial investigates the safety and tolerability of AMG 127 given as single and multiple doses. Part A and B enroll healthy adults aged 18–65, while Part C enrolls adults aged 40–75 with type 2 diabetes. The study compares AMG 127 to placebo and includes careful monitoring of vital signs and adverse events. Lead sponsor is Amgen with sites in California and Florida. The trial assesses short-term safety outcomes to inform future research in diabetes and metabolic health.
Why it matters
Potential benefit: If successful, AMG 127 could be deemed safe for progression to later-phase studies in people with type 2 diabetes.
How similar studies have gone: Previous early-phase trials of similar agents have focused on safety and tolerability; this study explores AMG 127 in both healthy and diabetic populations, which is a cautious, yet common, approach in early development.
Who can join: the full rules
Show full inclusion / 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
Where it's running
-
Orange County Research Center
Lake Forest, California, United States Recruiting -
Translational Clinical Research LLC
Aventura, Florida, United States Recruiting
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.