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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neuraly, Inc.

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