Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
28
Countries
1
Sites
1
Type 2 Diabetes Mellitus
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 14 Jan 2026 → ongoing
- Decision date (initial)
- 2025-11-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Type 2 Diabetes Mellitus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10067585 | Type 2 diabetes mellitus | 100000004861 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Temporarily halted | 28 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2026-01-14 | 2026-01-14 | 2026-03-30 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-128618
- Halt date
- 2026-03-30
- Member states concerned
- Germany
- Publication date
- 2026-04-13
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The IDMC in PRESTO (D7860C00006) conducted an ad-hoc data review, and the IDMC recommendation following the review is continuation of the PRESTO study but with modifications to the study protocol , that has immediate impact to current D7860C00005 study design.
Therefore, the sponsor has taken the decision to put study D7860C00005 on temporary hold.
For further information please refer to Urgent safety measure submitted on 3-Apr-2026. (business key: US-127473; Internal sponsor id: 2025-522551-25-00). - Follow-up measures
- Safety Follow up visit will be conducted for all participants as per current protocol.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-01 | Germany | Acceptable 2025-11-27
|
2025-11-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-16 | Germany | Acceptable 2025-11-27
|
2026-02-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-26 | Germany | Acceptable 2026-04-14
|
2026-04-14 |