Status:
COMPLETED
A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD
Lead Sponsor:
Neuraly, Inc.
Conditions:
Overweight and Obesity
Type2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 a...
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, su...
Eligibility Criteria
Inclusion
- Part A
- Type 2 diabetes ≥ 12 months.
- Treatment with diet and exercise or metformin monotherapy on stable dose for 3 months prior to screening
- HbA1c ≤ 10%).
- Body Mass Index (BMI) ≥ 25 and ≤ 40.0 kg/m2
- Part B Inclusion Criteria
- Type 2 diabetes ≥ 12 months.
- Treatment with diet and exercise or metformin monotherapy on stable dose for 3 months prior to screening
- HbA1c ≤ 10%
- BMI ≥ 30 kg/m2 and ≤ 40.0 kg/m2
- Waist circumference ≤ 57 inches
- Controlled attenuation parameter by FibroScan
- Liver fat fraction ≥ 10% by magnetic resonance imaging (MRI)
- Part A
Exclusion
- History of type 1 diabetes mellitus (T1DM)
- History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
- Uncontrolled hypertension
- Treatment with antihypertensive medication and statins not stable during the past 2 months prior to screening
- Treatment with thyroid hormones not stable during the past 3 months prior to screening
- History of any weight control treatment, including over-the-counter and herbal medication and supplements, or any medication with a labeled indication for weight loss or weight gain within 3 months prior to screening
- History of surgical treatment for obesity
- History of heart disease
- History of renal disease
- History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis, such as a history of cholelithiasis (without cholecystectomy) or alcohol abuse
- A history of or active chronic liver disease due to alcohol, auto-immune, HIV, HBV or active HCV-infection or NASH
- History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder requiring medical treatment
- Personal or family history of medullary thyroid carcinoma (MTC) or a genetic condition that predispose to MTC (i.e., multiple endocrine neoplasia type 2)
- Administration of Vaccines/Immunizations within 14 days prior to first dosing or if scheduled during the study. Vaccination for COVID-19 is allowed during the study if a washout period of 5 days after vaccine administration is followed before dosing.
- History of any major surgery within 6 months prior to screening
- Participation in any other clinical interventional study receiving active treatment within 30 days or 5 half-lives prior to screening, whichever is longer
- History of alcohol or illicit drug abuse including marijuana
- Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the investigational product
- PART B Exclusion Criteria
- History of type 1 diabetes mellitus (T1DM)
- History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
- Uncontrolled hypertension (treatment with medications must be stable)
- History of any weight control treatment
- History of surgical treatment for obesity
- History of heart disease
- History of renal disease
- Subjects with a history or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, pancreatic, immunological, dermatological, endocrine, genitourinary or hematological system.
- History or current diagnosis of acute or chronic pancreatitis
- History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder requiring medical treatment
- History of alcohol or illicit drug abuse including marijuana
- Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the investigational product
- Any history of clinically significant chronic liver disease
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2023
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT04812262
Start Date
February 24 2021
End Date
February 14 2023
Last Update
April 29 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Prosciento
Chula Vista, California, United States, 91911
2
Southwest General Healthcare Center
Fort Myers, Florida, United States, 33907
3
Combined Research Orlando
Orlando, Florida, United States, 32807
4
FDI Clinical Research
San Juan, Puerto Rico, 00927