A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD
NCT ID: NCT04812262
Last Updated: 2024-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
255 participants
INTERVENTIONAL
2021-02-24
2023-02-14
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Group A1 - Single Ascending Dose
DD01 Dose 1 (N=6) Placebo (N=2) Subcutaneous injection
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group A2, Single Ascending Dose
DD01 Dose 2 (N=6) Placebo (N=2) Subcutaneous injection
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group A3, Single Ascending Dose
DD01 Dose 3 (N=6) Placebo (N=2) Subcutaneous injection
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group A4, Single Ascending Dose
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group B2 - Multiple Ascending Dose
DD01 Dose 2 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group B3 - Multiple Ascending Dose
DD01 Dose 3 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group B4 - Multiple Ascending Dose
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group B5 - Multiple Ascending Dose
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group B6 - Multiple Ascending Dose
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group A5, Single Ascending Dose
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group A6, Single Ascending Dose
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group A7, Single Ascending Dose
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group A8, Single Ascending Dose
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group B7 - Multiple Ascending Dose
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Group B8 - Multiple Ascending Dose
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Interventions
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DD01
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
Placebo
Placebo drug of DD01, administered in a 1mL volume for injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
Exclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Neuraly, Inc.
INDUSTRY
Responsible Party
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Locations
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Prosciento
Chula Vista, California, United States
Southwest General Healthcare Center
Fort Myers, Florida, United States
Combined Research Orlando
Orlando, Florida, United States
FDI Clinical Research
San Juan, , Puerto Rico
Countries
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Other Identifiers
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DD01-DN-1
Identifier Type: -
Identifier Source: org_study_id
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