NCT06703658CompletedPhase 1
A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants With Type 2 Diabetes Mellitus
A Phase I, Randomised, Single-blind, Placebo-controlled, Single and Repeated Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5004 in Healthy Japanese Participants and With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 21 Mar 2025
Brief summary (registry, in English)
This Phase I study will gather important information on the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5004 in both healthy Japanese participants and Japanese participants with T2DM.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 29 Oct 2024
- Start date
- 2 Nov 2024
- Primary completion date
- 13 Mar 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06703658
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 35
- From 2 Nov 2024 to the primary completion date, 13 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has a clinically relevant acute or chronic medical condition or disease.
- History of acute pancreatitis and chronic pancreatitis, gallstones.
- Significant hepatic disease.
- Uncontrolled thyroid disease
Other
- Abnormal renal function.
- Known clinically significant gastric emptying abnormality
Who the study is looking for
- Japanese men or women, and 18-65 years of age inclusive, at the time of signing the informed consent.
- HbA1c ≤ 6.0%.
- Body weight ≥ 50.0 kg and BMI within the range 18.0-32.0 kg/m2.
- HbA1c ≥ 6.5% and ≤ 10.5%.
- Not on any other diabetic medications.
- Body weight ≥ 60.0 kg and BMI within the range 24.0-35.0 kg/m2
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.