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CompletedPhase 1

A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DR10624

A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-and-Multiple-Ascending Subcutaneous Doses of DR10624

Asset

DR10624

Subcutaneous · GLP-1 / glucagon / FGF21 triple

Listed sites

1

Recruiting sites

Enrollment

153

actual

Study population

Dyslipidemia, Healthy volunteers, Obesity / overweight

Key I/E criterion

BMI 18-32

Primary endpoint

One or more treatment-emergent adverse event (TEAE)

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 IDNCT05378893
Org study IDDR10624-101

Timeline

Milestones

Study first posted2022-05-18actual
Study start2022-06-22actual
Primary completion2024-10-10actual
Study completion2025-01-31actual
Last update posted2025-02-04actual

Assets

Investigational agents

Study populations

Who this study enrolls

DyslipidemiaHealthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.

2. Female subjects (heterosexually active, of childbearing potential, not pregnant, not trying to become pregnant, and not lactating) are eligible to participate if they agree to total abstinence from heterosexual intercourse or use a highly effective method of birth control listed below, from screening through until at least 30 days after the last dose of the study drug.

Male subjects with female partners of childbearing potential are eligible to participate if they are vasectomized, or agree to total abstinence from heterosexual intercourse, from screening through until at least 30 days after the last study dose, or use of an effective method of birth control listed above, from screening through until at least 30 days after the last study dose. Male subjects must refrain from sperm donation throughout the study and for 30 days after the last study dose.

3. The subject agrees to comply with all protocol requirements.

4. The subject is able to provide written informed consent.

Additional inclusion criteria for Part 1:

1. The subject is male or female 18 to 55 years of age, inclusive.

2. The subject has a body weight ≥50 kg at screening and a BMI of 18 to 32 kg/m2, inclusive, or.

3. The subject has a BMI of 30 to 40 kg/m2, inclusive, at screening in obesity subjects cohort.

Additional inclusion criteria for Part 2:

1. The subject is male or female 18 to 60 years of age, inclusive.

2. The subject has a BMI of 30 to 45 kg/m2 at screening, inclusive.

3. Fasting triglyceride ≥150 mg/dL (1.7 mmol/L), and <500 mg/dL (5.7 mmol/L), at screening.

Exclusion criteria

1. The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.

2. The subject has a personal or family history of medullary thyroid cancer, or multiple endocrine neoplasia syndrome Type 2, or a screening calcitonin ≥50 ng/L.

3. The subject has a history of chronic pancreatitis or episode of acute pancreatitis within 3 months of screening.

4. In Part 1, the subject has used any prescription medications (excluding oral contraceptives, paracetamol, and ibuprofen) within 14 days before the first dose of study drug. In Part 2, the subjects have been on stable lipid-lowering therapy <8 weeks before the first dose of study drug.

5. The subject has consumed alcohol within 48 hours before dosing or during the confinement period.

6. The subject is a smoker or has used tobacco, nicotine, or nicotine-containing products.

7. The subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption.

8. The subject has a positive test result for drugs of abuse and/or alcohol abuse at screening and check-in for the first inpatient period.

9. The subject is involved in strenuous activity or contact sports within 48 hours before admission.

10. The subject has donated blood or blood products >450 mL within 30 days before the first dose of study drug.

11. The subject has total cholesterol >10.3 mmol/L or triglycerides ≥5.7 mmol/L (500 mg/dL) at screening.

12. The subject has clinically significant history or presence of ECG findings as determined by the investigator at screening and check-in,

- Uncontrolled hypertension (defined as systolic blood pressure (SBP) ≥160 mmHg, and/or diastolic blood pressure (DBP) ≥100 mmHg), angina, bradycardia (if assessed as clinically significant by the investigator), or severe peripheral arterial circulatory disorders.

13. The subject has a history of relevant drug and/or food allergies (ie, allergy to DR10624 or excipients, or any significant food allergy that could preclude a standard diet in the clinical unit).

14. The subject has a history of severe allergic or anaphylactic reactions.

15. The subject has experienced a >5% loss in body weight within 2 months prior to screening.

16. Female subjects who are pregnant or lactating.

17. The subject has a positive test for severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). A positive rapid antigen test (RAT), isothermal nucleic acid amplification, or polymerase chain reaction (PCR) coronavirus disease-2019 (COVID-19) test during screening or at admission is acceptable provided the subject has a known previous COVID-19 infection ≥3 weeks prior to dosing, has recovered, and is now asymptomatic

18. The subject has received study drug in another investigational study within 30 days of dosing.

19. In the opinion of the investigator, the subject is not suitable for entry into the study.

Additional exclusion criteria for subjects in Part 2:

1. Subjects with coagulopathies.

2. Poorly controlled diabetes, defined as HbA1c >8.5% at screening.

3. The subject has been treated with the following anti-diabetic agents, glucagon-like peptide-1 receptor agonist (GLP-1Ra), dipeptidyl peptidase-4 inhibitors (DPP-4i), or insulin, within 30 days prior to screening until the follow-up visit.

4. The subjects have >2 × upper limit of normal (ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or >1.5 × ULN for bilirubin or alkaline phosphatase at screening.

5. Subjects with contraindications to MRI.

Endpoints (31)

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
10
Glycemic / diabetes
9
MASH / liver
4
Other (unclassified)
4
Weight & body composition
3
Cardiometabolic biomarkers
1

Weight & body composition

3 endpoints
Secondary/protocol endpoint

change in body weight

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

change in BMI

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

change in waist circumference

Time frame:baseline through Day 85

change from baseline, improvement

Glycemic / diabetes

9 endpoints
Secondary/protocol endpoint

change in fasting plasma glucose (FPG)

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

change in HbA1c

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

change in C-peptide

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

change in fasting insulin

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

change in homeostatic model assessment index of insulin resistance (HOMA-IR) and homeostatic model assessment index of beta-cell function (HOMA-B)

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

change in Partial area glucose level versus time curve from time 0 to 4 hours (△AUC0-4h)

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

change in Partial area insulin level versus time curve from time 0 to 4 hours (△AUC0-4h)

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

change in Partial area C-peptide level versus time curve from time 0 to 4 hours (△AUC0-4h)

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

change percentage of time spent of glucose in target range 3.9 to 10 mmol/L (TIR), time above target range (TAR), time below target range (TBR), 24-hour mean glucose, and glucose variability

Time frame:baseline through Day 85

descriptive

MASH / liver

4 endpoints
Secondary/protocol endpoint

change in hepatic fat fraction measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF ) in part 2

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

Change in liver stiffness by FibroScan in subjects with baseline hepatic fat of at least 8%

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

Change in the liver function parameters (ALT, AST, alkaline phosphatase (ALP), and gamma-glutamyltransferase (GGT))

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint

Change in Fibrosis 4 score (FIB-4) and non-alcoholic fatty liver disease fibrosis score (NFS)

Time frame:baseline through Day 85

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

change in fasting lipid profile

Time frame:baseline through Day 85

change from baseline, improvement

Safety / tolerability / PK

10 endpoints
Primary/protocol endpoint

Number of participants with one or more treatment-emergent adverse event (TEAE), serious adverse event (SAE) and adverse event of special interest (AESI).

Time frame:baseline through day 29(part 1)or day 106(part 2)

event count, event

Secondary/protocol endpoint

Area under the serum concentration versus time curve (AUC)

Time frame:baseline through day 29(part 1)or day 106(part 2)

concentration, descriptive

Secondary/protocol endpoint

Maximum observed serum concentration (Cmax)

Time frame:baseline through day 29(part 1)or day 106(part 2)

concentration, descriptive

Secondary/protocol endpoint

Time to reach maximum observed serum concentration (Tmax)

Time frame:baseline through day 29(part 1)or day 106(part 2)

time to event, event

Secondary/protocol endpoint

Terminal elimination half-life (t1/2)

Time frame:baseline through day 29(part 1)or day 106(part 2)

concentration, descriptive

Secondary/protocol endpoint

Mean residence time (MRT)

Time frame:baseline through day 29(part 1)or day 106(part 2)

descriptive

Secondary/protocol endpoint

Apparent clearance after extravascular administration (CL/F)

Time frame:baseline through day 29(part 1)or day 106(part 2)

concentration, descriptive

Secondary/protocol endpoint

Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vz/F)

Time frame:baseline through day 29(part 1)or day 106(part 2)

ratio, event

Secondary/protocol endpoint

AUC from time 0 to the time of the dosing interval (AUC0-t)

Time frame:baseline through day 106(part 2)

concentration, descriptive

Secondary/protocol endpoint

change in Partial area glucagon level versus time curve from time 0 to 4 hours (△AUC0-4h)

Time frame:baseline through Day 85

change from baseline, event

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

Accumulation ratio (AR)

Time frame:baseline through day 106(part 2)

ratio, improvement

Secondary/protocol endpoint/low confidence

Predose concentrations(Ctrough)

Time frame:baseline through day 106(part 2)

concentration, descriptive

Secondary/protocol endpoint/low confidence

change in adiponectin

Time frame:baseline through Day 85

change from baseline, improvement

Secondary/protocol endpoint/low confidence

change in glucagon

Time frame:baseline through Day 85

change from baseline, improvement

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.