A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD
Completed · Phase 1 · Has a placebo group
Conditions studied: Overweight and Obesity, Type2 Diabetes, NAFLD
In brief
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).
Key facts
- Study ID
- NCT04812262
- Run by
- Neuraly, Inc.
- People needed
- 255
- Starts
- 2021-02-24
- Expected to finish
- 2023-02-14
- Last updated by the study team
- 2024-04-29
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Prosciento — Chula Vista, California, United States
- Southwest General Healthcare Center — Fort Myers, Florida, United States
- Combined Research Orlando — Orlando, Florida, United States
- FDI Clinical Research — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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