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

NCT04812262 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2024-04-29

No results posted yet for this 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).

Conditions

  • Overweight and Obesity
  • Type2 Diabetes
  • NAFLD

Interventions

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

Sponsors & Collaborators

  • Neuraly, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2022-12-20
Completion
2023-02-14
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04812262 on ClinicalTrials.gov