← Trials/Trial dossier/NCT05378893
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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
3 endpointschange in body weight
Time frame:baseline through Day 85
change from baseline, improvement
change in BMI
Time frame:baseline through Day 85
change from baseline, improvement
change in waist circumference
Time frame:baseline through Day 85
change from baseline, improvement
Glycemic / diabetes
9 endpointschange in fasting plasma glucose (FPG)
Time frame:baseline through Day 85
change from baseline, improvement
change in HbA1c
Time frame:baseline through Day 85
change from baseline, improvement
change in C-peptide
Time frame:baseline through Day 85
change from baseline, improvement
change in fasting insulin
Time frame:baseline through Day 85
change from baseline, improvement
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
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
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
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
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 endpointschange 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
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
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
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 endpointchange in fasting lipid profile
Time frame:baseline through Day 85
change from baseline, improvement
Safety / tolerability / PK
10 endpointsNumber 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
Area under the serum concentration versus time curve (AUC)
Time frame:baseline through day 29(part 1)or day 106(part 2)
concentration, descriptive
Maximum observed serum concentration (Cmax)
Time frame:baseline through day 29(part 1)or day 106(part 2)
concentration, descriptive
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
Terminal elimination half-life (t1/2)
Time frame:baseline through day 29(part 1)or day 106(part 2)
concentration, descriptive
Mean residence time (MRT)
Time frame:baseline through day 29(part 1)or day 106(part 2)
descriptive
Apparent clearance after extravascular administration (CL/F)
Time frame:baseline through day 29(part 1)or day 106(part 2)
concentration, descriptive
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
AUC from time 0 to the time of the dosing interval (AUC0-t)
Time frame:baseline through day 106(part 2)
concentration, descriptive
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 endpointsAccumulation ratio (AR)
Time frame:baseline through day 106(part 2)
ratio, improvement
Predose concentrations(Ctrough)
Time frame:baseline through day 106(part 2)
concentration, descriptive
change in adiponectin
Time frame:baseline through Day 85
change from baseline, improvement
change in glucagon
Time frame:baseline through Day 85
change from baseline, improvement
Provenance
Sources
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.