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NCT04812262 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD
A Phase 1 study, sponsored by Neuraly.
- Completed
- Registry status
- Phase 1
- Development phase
- 255
- Enrollment target
NCT04812262: Completed Phase 1 study, sponsored by Neuraly.
NCT04812262 is a Phase 1 study that has completed, run by Neuraly. The registered enrollment target is 255 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (325% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04812262, a Phase 1 study, has completed, sponsored by Neuraly.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 255 participants
- Enrollment target
Study Summary
This is a Phase 1, first in human (FiH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to investigate the safety, tolerability, PK and PD of DD01 administered by subcutaneous (SC) injection in overweight/obese subjects with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD). The study will be conducted in 2 Parts (Part A and B), with up to 8 cohorts included in each part (Part A; Cohorts A1 to A8 and Part B; Cohorts B2 to B8).
Interventions
- DRUG Placebo
- DRUG DD01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2023-02-14 |
| Phase | Phase 1 |
What the finished NCT04812262 record still lists
NCT04812262 is an interventional study that assigns participants to a tested intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (325% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04812262 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04812262 about?
NCT04812262 is a clinical study titled "A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD". This is a Phase 1, first in human (FiH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to investigate the safety, tolerability, PK and PD of DD01 administered by subcutaneous (SC) injection in overweight/obese subjects with type 2 d...
What is the current status of trial NCT04812262?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 255 participants. The study started on 2021-02-24. Estimated completion is 2023-02-14.
What interventions are being tested in trial NCT04812262?
The interventions under investigation include: Placebo (DRUG), DD01 (DRUG).
Who is sponsoring clinical trial NCT04812262?
This trial is sponsored by Neuraly, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04812262's enrollment target sits among peer trials
255 168th of 2000 higher than 1,833 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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