Clinical trial Recruiting at 2 sites Phase 1 Interventional Ages 18 to 75

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

PhasePhase 1
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment162 (estimated)
SponsorAmgen
Industry-sponsored
Locations2 sites (Lake Forest, California and 1 other locations)
StatusRecruiting
StartedJune 11, 2026
Main results expectedOctober 2, 2027
Study endsOctober 2, 2027
Registry record updatedAugust 3, 2026
Trial IDNCT07590193 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.