Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04812262
Other study ID # DD01-DN-1
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 24, 2021
Est. completion date February 14, 2023

Study information

Verified date April 2024
Source Neuraly, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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, 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.


Recruitment information / eligibility

Status Completed
Enrollment 255
Est. completion date February 14, 2023
Est. primary completion date December 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Puerto Rico FDI Clinical Research San Juan
United States Prosciento Chula Vista California
United States Southwest General Healthcare Center Fort Myers Florida
United States Combined Research Orlando Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Neuraly, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-related adverse events and serious adverse events Part A - 43 days
Primary Number of participants with treatment-related adverse events and serious adverse events (TEAEs) Part B - 57 days
Primary Number of participants with clinically significant abnormalities in clinical laboratory values Part A - 43 days
Primary Number of participants with clinically significant abnormalities in clinical laboratory values Part B - 57 days
Primary Number of participants with clinically significant abnormalities in physical examinations Part A - 43 days
Primary Number of participants with clinically significant abnormalities in physical examinations Part B - 57 days
Primary Number of participants with clinically significant abnormalities in vital signs Part A - 43 days
Primary Number of participants with clinically significant abnormalities in vital signs Part B - 57 days
Primary Blood Pressure assessed by 24-hour ambulatory blood pressure monitoring (ABPM) Part A - 43 days
Primary Blood Pressure assessed by 24-hour ambulatory blood pressure monitoring (ABPM) Part B - 57 days
Primary Heart Rate assessed by 24-hour ambulatory electrocardiography monitoring reader) Part A - 43 days
Primary Heart Rate assessed by 24-hour ambulatory electrocardiography monitoring reader) Part B - 57 days
Primary Number of participants with clinically significant abnormalities in 12-lead ECGs Part A - 43 days
Primary Number of participants with clinically significant abnormalities in 12-lead ECGs Part B - 57 days
Secondary Maximum observed blood/plasma concentration of DD01 Maximum observed blood/plasma concentration (Cmax) Part A - 43 days
Secondary Maximum observed blood/plasma concentration of DD01 Maximum observed blood/plasma concentration (Cmax) Part B - 57 days
Secondary Time of the maximum observed blood/plasma concentration of DD01 Time of the maximum observed blood/plasma concentration (Tmax) Part A - 43 days
Secondary Time of the maximum observed blood/plasma concentration of DD01 Time of the maximum observed blood/plasma concentration (Tmax) Part B - 57 days
Secondary Apparent blood/plasma terminal elimination half life of DD01 Apparent blood/plasma terminal elimination half life (t1/2) Part A - 43 days
Secondary Apparent blood/plasma terminal elimination half life of DD01 Apparent blood/plasma terminal elimination half life (t1/2) Part B - 57 days
Secondary Termination elimination rate constant of DD01 Termination elimination rate constant (kel) Part A - 43 days
Secondary Termination elimination rate constant of DD01 Termination elimination rate constant (kel) Part B - 57 days
Secondary Apparent total blood/plasma clearance of DD01 Apparent total blood/plasma clearance (CL/F) Part A - 43 days
Secondary Apparent total blood/plasma clearance of DD01 Apparent total blood/plasma clearance (CL/F) Part B - 57 days
Secondary Apparent volume of distribution of DD01 Apparent volume of distribution(Vz/F) Part A - 43 days
Secondary Apparent volume of distribution of DD01 Apparent volume of distribution(Vz/F) Part B - 57 days
Secondary Area under the blood/plasma concentration time curve from time zero to the time of the last quantifiable concentration of DD01 Area under the blood/plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC0-t) Part A - 43 days
Secondary Area under the blood/plasma concentration time curve from time zero to the time of the last quantifiable concentration of DD01 Area under the blood/plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC0-t) Part B - 57 days
Secondary Area under the blood/plasma concentration time curve from time zero to 144 hours postdose of DD01 Area under the blood/plasma concentration time curve from time zero to 144 hours postdose (AUC0-144) Part A - 43 days
Secondary Area under the blood/plasma concentration time curve from time zero to 144 hours postdose of DD01 Area under the blood/plasma concentration time curve from time zero to 144 hours postdose (AUC0-144) Part B - 57 days
Secondary Area under the blood/plasma concentration time curve from time zero to 216 hours postdose of DD01 Area under the blood/plasma concentration time curve from time zero to 216 hours postdose (AUC0-216) Part A - 43 days
Secondary Area under the blood/plasma concentration time curve from time zero to 216 hours postdose of DD01 Area under the blood/plasma concentration time curve from time zero to 216 hours postdose (AUC0-216) Part B - 57 days
Secondary Area under the blood/plasma concentration time curve from time zero to 168 hours postdose of DD01 Part B only: Area under the blood/plasma concentration time curve from time zero to 168 hours postdose (AUC0-168) Part B - 57 days
Secondary Number of participants with antidrug antibodies (ADAs) Part A - 43 days
Secondary Number of participants with antidrug antibodies (ADAs) Part B - 57 days
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Recruiting NCT05354245 - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL) N/A
Completed NCT03602001 - Attentive Eating for Weight Loss N/A
Recruiting NCT06269159 - The Power of 24-hour: Co-designing Intervention Components
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02996864 - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II N/A
Completed NCT04647149 - Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity N/A
Terminated NCT03914066 - A Group-based Treatment of Overweight and Obesity in Primary Care N/A
Completed NCT03685656 - Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers N/A
Completed NCT05051579 - A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities Phase 2
Completed NCT04611477 - Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals N/A
Active, not recruiting NCT05330247 - Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study N/A
Completed NCT03599115 - Effects of Inhibitory Control Training in Eating Behaviors N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Recruiting NCT05938894 - Train Your Brain - Executive Function N/A
Recruiting NCT05987306 - A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss N/A
Completed NCT03792685 - Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention N/A
Completed NCT05055362 - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study N/A
Completed NCT04520256 - Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy Phase 2/Phase 3
Completed NCT04979234 - A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome N/A