GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

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

Lead sponsor

Neuraly, Inc.

Asset

DD01

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

255

actual

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-40•HbA1c ≤10%

Primary endpoints

•Treatment-related adverse events and serious adverse events•Treatment-related adverse events and serious adverse events (TEAEs)•Clinically significant abnormalities in clinical laboratory values

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04812262

Org study IDDD01-DN-1

Timeline

Milestones

Study start2021-02-24actual

Study first posted2021-03-23actual

Primary completion2022-12-20actual

Study completion2023-02-14actual

Last update posted2024-04-29actual

Assets

Investigational agents

DD01

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Eligibility 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

Endpoints (35)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Cardiometabolic biomarkers

Other (unclassified)

Cardiometabolic biomarkers

4 endpoints

Primary/protocol endpoint

Blood Pressure assessed by 24-hour ambulatory blood pressure monitoring (ABPM)

Time frame:Part A - 43 days

descriptive

Primary/protocol endpoint

Blood Pressure assessed by 24-hour ambulatory blood pressure monitoring (ABPM)

Time frame:Part B - 57 days

descriptive

Primary/protocol endpoint

Heart Rate assessed by 24-hour ambulatory electrocardiography monitoring reader)

Time frame:Part A - 43 days

descriptive

Primary/protocol endpoint

Heart Rate assessed by 24-hour ambulatory electrocardiography monitoring reader)

Time frame:Part B - 57 days

descriptive

Safety / tolerability / PK

27 endpoints

Primary/protocol endpoint

Number of participants with treatment-related adverse events and serious adverse events

Time frame:Part A - 43 days

event count, event

Primary/protocol endpoint

Number of participants with treatment-related adverse events and serious adverse events (TEAEs)

Time frame:Part B - 57 days

event count, event

Primary/protocol endpoint

Number of participants with clinically significant abnormalities in clinical laboratory values

Time frame:Part A - 43 days

event count, event

Primary/protocol endpoint

Number of participants with clinically significant abnormalities in clinical laboratory values

Time frame:Part B - 57 days

event count, event

Primary/protocol endpoint

Number of participants with clinically significant abnormalities in physical examinations

Time frame:Part A - 43 days

event count, event

Primary/protocol endpoint

Number of participants with clinically significant abnormalities in physical examinations

Time frame:Part B - 57 days

event count, event

Primary/protocol endpoint

Number of participants with clinically significant abnormalities in vital signs

Time frame:Part A - 43 days

event count, event

Primary/protocol endpoint

Number of participants with clinically significant abnormalities in vital signs

Time frame:Part B - 57 days

event count, event

Primary/protocol endpoint

Number of participants with clinically significant abnormalities in 12-lead ECGs

Time frame:Part A - 43 days

event count, event

Primary/protocol endpoint

Number of participants with clinically significant abnormalities in 12-lead ECGs

Time frame:Part B - 57 days

event count, event

Secondary/protocol endpoint

Maximum observed blood/plasma concentration of DD01

Time frame:Part A - 43 days

concentration, descriptive

Secondary/protocol endpoint

Maximum observed blood/plasma concentration of DD01

Time frame:Part B - 57 days

concentration, descriptive

Secondary/protocol endpoint

Time of the maximum observed blood/plasma concentration of DD01

Time frame:Part A - 43 days

concentration, descriptive

Secondary/protocol endpoint

Time of the maximum observed blood/plasma concentration of DD01

Time frame:Part B - 57 days

concentration, descriptive

Secondary/protocol endpoint

Apparent total blood/plasma clearance of DD01

Time frame:Part A - 43 days

concentration, descriptive

Secondary/protocol endpoint

Apparent total blood/plasma clearance of DD01

Time frame:Part B - 57 days

concentration, descriptive

Secondary/protocol endpoint

Apparent volume of distribution of DD01

Time frame:Part A - 43 days

descriptive

Secondary/protocol endpoint

Apparent volume of distribution of DD01

Time frame:Part B - 57 days

descriptive

Secondary/protocol endpoint

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

concentration, descriptive

Secondary/protocol endpoint

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

concentration, descriptive

Secondary/protocol endpoint

Area under the blood/plasma concentration time curve from time zero to 144 hours postdose of DD01

Time frame:Part A - 43 days

concentration, descriptive

Secondary/protocol endpoint

Area under the blood/plasma concentration time curve from time zero to 144 hours postdose of DD01

Time frame:Part B - 57 days

concentration, descriptive

Secondary/protocol endpoint

Area under the blood/plasma concentration time curve from time zero to 216 hours postdose of DD01

Time frame:Part A - 43 days

concentration, descriptive

Secondary/protocol endpoint

Area under the blood/plasma concentration time curve from time zero to 216 hours postdose of DD01

Time frame:Part B - 57 days

concentration, descriptive

Secondary/protocol endpoint

Area under the blood/plasma concentration time curve from time zero to 168 hours postdose of DD01

Time frame:Part B - 57 days

concentration, descriptive

Secondary/protocol endpoint

Number of participants with antidrug antibodies (ADAs)

Time frame:Part A - 43 days

event count, event

Secondary/protocol endpoint

Number of participants with antidrug antibodies (ADAs)

Time frame:Part B - 57 days

event count, event

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Apparent blood/plasma terminal elimination half life of DD01

Time frame:Part A - 43 days

concentration, descriptive

Secondary/protocol endpoint/low confidence

Apparent blood/plasma terminal elimination half life of DD01

Time frame:Part B - 57 days

concentration, descriptive

Secondary/protocol endpoint/low confidence

Termination elimination rate constant of DD01

Time frame:Part A - 43 days

descriptive

Secondary/protocol endpoint/low confidence

Termination elimination rate constant of DD01

Time frame:Part B - 57 days

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.