Overweight and ObesityPhase 1NCT04812262
A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD
A Phase 1 study testing DD01 in people with Overweight and Obesity and Type2 Diabetes, run by Neuraly, Inc. at 4 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight and Obesity, Type2 Diabetes, NAFLD
- What is being tested?
- DD01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 24 Feb 2021to 14 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Prosciento
Chula Vista, California, 91911
Southwest General Healthcare Center
Fort Myers, Florida, 33907
Combined Research Orlando
Orlando, Florida, 32807
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DD01 in Overweight/Obese Subjects With T2DM and NAFLD
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).
Read the 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, 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
- Overweight and Obesity, Type2 Diabetes, NAFLD
- Being tested
- DD01, Placebo
- Keywords
- Liver Disease
- Medical subject headings
- Overweight, Obesity, Non-alcoholic Fatty Liver Disease, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DD01Drug
The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
PlaceboDrug
Placebo drug of DD01, administered in a 1mL volume for injection
| Study group | Role | What they receive |
|---|---|---|
| Group A1 - Single Ascending Dose | Experimental | DD01 Dose 1 (N=6) Placebo (N=2) Subcutaneous injection Receives: Drug: DD01; Drug: Placebo |
| Group A2, Single Ascending Dose | Experimental | DD01 Dose 2 (N=6) Placebo (N=2) Subcutaneous injection Receives: Drug: DD01; Drug: Placebo |
| Group A3, Single Ascending Dose | Experimental | DD01 Dose 3 (N=6) Placebo (N=2) Subcutaneous injection Receives: Drug: DD01; Drug: Placebo |
| Group A4, Single Ascending Dose | Experimental | DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection Receives: Drug: DD01; Drug: Placebo |
| Group B2 - Multiple Ascending Dose | Experimental | DD01 Dose 2 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks Receives: Drug: DD01; Drug: Placebo |
| Group B3 - Multiple Ascending Dose | Experimental | DD01 Dose 3 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks Receives: Drug: DD01; Drug: Placebo |
| Group B4 - Multiple Ascending Dose | Experimental | DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks Receives: Drug: DD01; Drug: Placebo |
| Group B5 - Multiple Ascending Dose | Experimental | DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks Receives: Drug: DD01; Drug: Placebo |
| Group B6 - Multiple Ascending Dose | Experimental | DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks Receives: Drug: DD01; Drug: Placebo |
| Group A5, Single Ascending Dose | Experimental | DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection Receives: Drug: DD01; Drug: Placebo |
| Group A6, Single Ascending Dose | Experimental | DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection Receives: Drug: DD01; Drug: Placebo |
| Group A7, Single Ascending Dose | Experimental | DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection Receives: Drug: DD01; Drug: Placebo |
| Group A8, Single Ascending Dose | Experimental | DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection Receives: Drug: DD01; Drug: Placebo |
| Group B7 - Multiple Ascending Dose | Experimental | DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks Receives: Drug: DD01; Drug: Placebo |
| Group B8 - Multiple Ascending Dose | Experimental | DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks Receives: Drug: DD01; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events and serious adverse events
Measured: Part A - 43 days
Number of participants with treatment-related adverse events and serious adverse events (TEAEs)
Measured: Part B - 57 days
Number of participants with clinically significant abnormalities in clinical laboratory values
Measured: Part A - 43 days
Number of participants with clinically significant abnormalities in clinical laboratory values
Measured: Part B - 57 days
Number of participants with clinically significant abnormalities in physical examinations
Measured: Part A - 43 days
Number of participants with clinically significant abnormalities in physical examinations
Measured: Part B - 57 days
Number of participants with clinically significant abnormalities in vital signs
Measured: Part A - 43 days
Number of participants with clinically significant abnormalities in vital signs
Measured: Part B - 57 days
Blood Pressure assessed by 24-hour ambulatory blood pressure monitoring (ABPM)
Measured: Part A - 43 days
Blood Pressure assessed by 24-hour ambulatory blood pressure monitoring (ABPM)
Measured: Part B - 57 days
Heart Rate assessed by 24-hour ambulatory electrocardiography monitoring reader)
Measured: Part A - 43 days
Heart Rate assessed by 24-hour ambulatory electrocardiography monitoring reader)
Measured: Part B - 57 days
Number of participants with clinically significant abnormalities in 12-lead ECGs
Measured: Part A - 43 days
Number of participants with clinically significant abnormalities in 12-lead ECGs
Measured: Part B - 57 days
Secondary outcomes (21)
Maximum observed blood/plasma concentration of DD01
Maximum observed blood/plasma concentration (Cmax)
Measured: Part A - 43 days
Maximum observed blood/plasma concentration of DD01
Maximum observed blood/plasma concentration (Cmax)
Measured: Part B - 57 days
Time of the maximum observed blood/plasma concentration of DD01
Time of the maximum observed blood/plasma concentration (Tmax)
Measured: Part A - 43 days
Time of the maximum observed blood/plasma concentration of DD01
Time of the maximum observed blood/plasma concentration (Tmax)
Measured: Part B - 57 days
Apparent blood/plasma terminal elimination half life of DD01
Apparent blood/plasma terminal elimination half life (t1/2)
Measured: Part A - 43 days
Apparent blood/plasma terminal elimination half life of DD01
Apparent blood/plasma terminal elimination half life (t1/2)
Measured: Part B - 57 days
Termination elimination rate constant of DD01
Termination elimination rate constant (kel)
Measured: Part A - 43 days
Termination elimination rate constant of DD01
Termination elimination rate constant (kel)
Measured: Part B - 57 days
Apparent total blood/plasma clearance of DD01
Apparent total blood/plasma clearance (CL/F)
Measured: Part A - 43 days
Apparent total blood/plasma clearance of DD01
Apparent total blood/plasma clearance (CL/F)
Measured: Part B - 57 days
Apparent volume of distribution of DD01
Apparent volume of distribution(Vz/F)
Measured: Part A - 43 days
Apparent volume of distribution of DD01
Apparent volume of distribution(Vz/F)
Measured: Part B - 57 days
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)
Measured: Part A - 43 days
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)
Measured: Part B - 57 days
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)
Measured: Part A - 43 days
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)
Measured: Part B - 57 days
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)
Measured: Part A - 43 days
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)
Measured: Part B - 57 days
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)
Measured: Part B - 57 days
Number of participants with antidrug antibodies (ADAs)
Measured: Part A - 43 days
Number of participants with antidrug antibodies (ADAs)
Measured: Part B - 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start24 Feb 2021
- Primary completion20 Dec 2022
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A - Cohorts A1, A2, A3, A4, A5, A6, A7 \& A8 Part B - Cohorts B2, B3, B4, B5, B6, B7 \& B8
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuraly, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812262
- Sponsor's protocol ID
- DD01-DN-1
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2021
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DD01 in Overweight/Obese Subjects With T2DM and NAFLD
- ClinicalTrials.gov ID
- NCT04812262
- Acronym / sponsor ID
- DD01-DN-1
- Conditions
- Overweight and Obesity, Type2 Diabetes, NAFLD
- Keywords
- Liver Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Neuraly, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 15
- Model description
- Part A - Cohorts A1, A2, A3, A4, A5, A6, A7 \& A8 Part B - Cohorts B2, B3, B4, B5, B6, B7 \& B8
| Arm | Type | Receives |
|---|---|---|
| Group A1 - Single Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 1 (N=6) Placebo (N=2) Subcutaneous injection |
| Group A2, Single Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 2 (N=6) Placebo (N=2) Subcutaneous injection |
| Group A3, Single Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 3 (N=6) Placebo (N=2) Subcutaneous injection |
| Group A4, Single Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection |
| Group B2 - Multiple Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 2 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks |
| Group B3 - Multiple Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 3 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks |
| Group B4 - Multiple Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks |
| Group B5 - Multiple Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks |
| Group B6 - Multiple Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks |
| Group A5, Single Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection |
| Group A6, Single Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection |
| Group A7, Single Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection |
| Group A8, Single Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection |
| Group B7 - Multiple Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks |
| Group B8 - Multiple Ascending Dose | Experimental | Drug: DD01, Drug: PlaceboDD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DD01The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection. | Drug | Group A1 - Single Ascending Dose, Group A2, Single Ascending Dose, Group A3, Single Ascending Dose, Group A4, Single Ascending Dose, Group A5, Single Ascending Dose, Group A6, Single Ascending Dose, Group A7, Single Ascending Dose, Group A8, Single Ascending Dose, Group B2 - Multiple Ascending Dose, Group B3 - Multiple Ascending Dose, Group B4 - Multiple Ascending Dose, Group B5 - Multiple Ascending Dose, Group B6 - Multiple Ascending Dose, Group B7 - Multiple Ascending Dose, Group B8 - Multiple Ascending Dose |
| PlaceboPlacebo drug of DD01, administered in a 1mL volume for injection | Drug | Group A1 - Single Ascending Dose, Group A2, Single Ascending Dose, Group A3, Single Ascending Dose, Group A4, Single Ascending Dose, Group A5, Single Ascending Dose, Group A6, Single Ascending Dose, Group A7, Single Ascending Dose, Group A8, Single Ascending Dose, Group B2 - Multiple Ascending Dose, Group B3 - Multiple Ascending Dose, Group B4 - Multiple Ascending Dose, Group B5 - Multiple Ascending Dose, Group B6 - Multiple Ascending Dose, Group B7 - Multiple Ascending Dose, Group B8 - Multiple Ascending Dose |
Primary outcome
Number of participants with treatment-related adverse events and serious adverse events
Time frame: Part A - 43 days
Number of participants with treatment-related adverse events and serious adverse events (TEAEs)
Time frame: Part B - 57 days
Number of participants with clinically significant abnormalities in clinical laboratory values
Time frame: Part A - 43 days
Number of participants with clinically significant abnormalities in clinical laboratory values
Time frame: Part B - 57 days
Number of participants with clinically significant abnormalities in physical examinations
Time frame: Part A - 43 days
Number of participants with clinically significant abnormalities in physical examinations
Time frame: Part B - 57 days
Number of participants with clinically significant abnormalities in vital signs
Time frame: Part A - 43 days
Number of participants with clinically significant abnormalities in vital signs
Time frame: Part B - 57 days
Blood Pressure assessed by 24-hour ambulatory blood pressure monitoring (ABPM)
Time frame: Part A - 43 days
Blood Pressure assessed by 24-hour ambulatory blood pressure monitoring (ABPM)
Time frame: Part B - 57 days
Heart Rate assessed by 24-hour ambulatory electrocardiography monitoring reader)
Time frame: Part A - 43 days
Heart Rate assessed by 24-hour ambulatory electrocardiography monitoring reader)
Time frame: Part B - 57 days
Number of participants with clinically significant abnormalities in 12-lead ECGs
Time frame: Part A - 43 days
Number of participants with clinically significant abnormalities in 12-lead ECGs
Time frame: Part B - 57 days
21 secondary outcomes
Maximum observed blood/plasma concentration of DD01
Time frame: Part A - 43 days
Maximum observed blood/plasma concentration of DD01
Time frame: Part B - 57 days
Time of the maximum observed blood/plasma concentration of DD01
Time frame: Part A - 43 days
Time of the maximum observed blood/plasma concentration of DD01
Time frame: Part B - 57 days
Apparent blood/plasma terminal elimination half life of DD01
Time frame: Part A - 43 days
Apparent blood/plasma terminal elimination half life of DD01
Time frame: Part B - 57 days
Termination elimination rate constant of DD01
Time frame: Part A - 43 days
Termination elimination rate constant of DD01
Time frame: Part B - 57 days
Apparent total blood/plasma clearance of DD01
Time frame: Part A - 43 days
Apparent total blood/plasma clearance of DD01
Time frame: Part B - 57 days
Apparent volume of distribution of DD01
Time frame: Part A - 43 days
Apparent volume of distribution of DD01
Time frame: Part B - 57 days
Area under the blood/plasma concentration time curve from time zero to the time of the last quantifiable concentration of DD01
Time frame: Part A - 43 days
Area under the blood/plasma concentration time curve from time zero to the time of the last quantifiable concentration of DD01
Time frame: Part B - 57 days
Area under the blood/plasma concentration time curve from time zero to 144 hours postdose of DD01
Time frame: Part A - 43 days
Area under the blood/plasma concentration time curve from time zero to 144 hours postdose of DD01
Time frame: Part B - 57 days
Area under the blood/plasma concentration time curve from time zero to 216 hours postdose of DD01
Time frame: Part A - 43 days
Area under the blood/plasma concentration time curve from time zero to 216 hours postdose of DD01
Time frame: Part B - 57 days
Area under the blood/plasma concentration time curve from time zero to 168 hours postdose of DD01
Time frame: Part B - 57 days
Number of participants with antidrug antibodies (ADAs)
Time frame: Part A - 43 days
Number of participants with antidrug antibodies (ADAs)
Time frame: Part B - 57 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DD01 in people with Overweight and Obesity and Type2 Diabetes, run by Neuraly, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events and serious adverse events (time frame: Part A - 43 days). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.