NCT04812262

A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DD01 in Overweight/Obese Subjects With T2DM and NAFLD

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Neuraly, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Part A (SAD): In Part A, subjects will receive a single dose of study drug, and the safety and efficacy of DD01 will be evaluated in overweight/obese subjects with T2DM. Part B (MAD): In Part B, subjects will receive once-weekly doses of the study drug for 4 weeks, and the safety and efficacy of DD01 will be evaluated in overweight/obese subjects with T2DM and NAFLD.

Conditions

• Overweight and Obesity
• Type2 Diabetes
• NAFLD

Interventions

Type	Name	Description
DRUG	DD01	The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
DRUG	Placebo	Placebo drug of DD01, administered in a 1mL volume for injection

Timeline

• Start date: 2021-02-24
• Primary completion: 2022-12-20
• Completion: 2023-02-14
• First posted: 2021-03-23
• Last updated: 2024-04-29

Locations

4 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study