Fort Myers, Florida 33907

  • NAFLD

Purpose:

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 4 cohorts included in each part (Part A; Cohorts A1 to A4 and Part B; Cohorts B1 to B4).


Study summary:

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.


Criteria:

Part A 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%). - 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 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 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


NCT ID:

NCT04812262


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Fort Myers, Florida 33907
United States

Brian Warnsky
Phone: 407-476-0514
Email: brian.swghcc@gmail.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

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