Healthy, Obesity, MetabolicallyPhase 1NCT05378893
A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DR10624
A Phase 1 study testing DR10624 for injection in people with Healthy, Obesity, Metabolically, run by Zhejiang Doer Biologics Co., Ltd. at 1 site in New Zealand.
Trial summary
DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Obesity, Metabolically
- What is being tested?
- DR10624 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteNew Zealand
- Study dates
- 22 Jun 2022to 31 Jan 2025
- Phase
- Phase 1
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
- The subject agrees to comply with all protocol requirements.
- The subject is able to provide written informed consent.
- Additional inclusion criteria for Part 1:
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- The subject is male or female 18 to 55 years of age, inclusive.
- The subject has a body weight ≥50 kg at screening and a BMI of 18 to 32 kg/m2, inclusive, or.
- The subject has a BMI of 30 to 40 kg/m2, inclusive, at screening in obesity subjects cohort.
- Additional inclusion criteria for Part 2:
- The subject is male or female 18 to 60 years of age, inclusive.
- The subject has a BMI of 30 to 45 kg/m2 at screening, inclusive.
- Fasting triglyceride ≥150 mg/dL (1.7 mmol/L), and <500 mg/dL (5.7 mmol/L), at screening.
Who cannot join
- 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.
- 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.
- The subject has a history of chronic pancreatitis or episode of acute pancreatitis within 3 months of screening.
- 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.
- The subject has consumed alcohol within 48 hours before dosing or during the confinement period.
- The subject is a smoker or has used tobacco, nicotine, or nicotine-containing products.
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- The subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption.
- 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.
- The subject is involved in strenuous activity or contact sports within 48 hours before admission.
- The subject has donated blood or blood products >450 mL within 30 days before the first dose of study drug.
- The subject has total cholesterol >10.3 mmol/L or triglycerides ≥5.7 mmol/L (500 mg/dL) at screening.
- 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.
- 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).
- The subject has a history of severe allergic or anaphylactic reactions.
- The subject has experienced a >5% loss in body weight within 2 months prior to screening.
- Female subjects who are pregnant or lactating.
- 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
- The subject has received study drug in another investigational study within 30 days of dosing.
- In the opinion of the investigator, the subject is not suitable for entry into the study.
- Additional exclusion criteria for subjects in Part 2:
- Subjects with coagulopathies.
- Poorly controlled diabetes, defined as HbA1c >8.5% at screening.
- 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.
- 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.
- Subjects with contraindications to MRI.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
New Zealand Clinical Research
Christchurch, Canterbury, 8011
About this study
Official title: 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
DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities. The objectives of the planned clinical investigation will be to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single- and multiple-ascending doses of DR10624 via subcutaneous (SubQ) injection in a randomized, placebo-controlled, double-blind study.
Read the detailed description
This study includes 2 parts( 1 and 2). Part 1 involves a single dose of DR10624 taken as a subcutaneous injection just under the skin. Part 2 involve multiple doses of DR10624 taken as a subcutaneous injection (SC) just under the skin. Each participant will enroll in only one part.
- Conditions
- Healthy, Obesity, Metabolically
- Being tested
- DR10624 for injection, Placebo
- Medical subject headings
- Obesity, Metabolically Benign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DR10624 for injectionDrug
administered via subcutaneous injection
PlaceboDrug
administered via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Single-ascending dose：Part1：DR10624 | Experimental | Escalating doses of DR10624 for injection administered subcutaneously in healthy participants or obese but otherwise healthy participants Receives: Drug: DR10624 for injection |
| Single-ascending dose：Part1：placebo | Placebo comparator | Escalating doses of placebo for injection administered subcutaneously in in healthy participants or obese but otherwise healthy participants Receives: Drug: Placebo |
| Multiple-ascending dose：Part2：DR10624 | Experimental | Escalating doses of DR10624 for injection administered subcutaneously in obese adult subjects with moderate hypertriglyceridemia Receives: Drug: DR10624 for injection |
| Multiple-ascending dose：Part2：placebo | Placebo comparator | Escalating doses of placebo for injection administered subcutaneously in obese adult subjects with moderate hypertriglyceridemia Receives: Drug: Placebo |
| Single-ascending dose：Part3：DR10624 | Experimental | A SAD part in Chinese healthy adult subjects or overweight or obese adults but otherwise healthy adult subjects. Receives: Drug: DR10624 for injection |
| Single-ascending dose：Part3：placebo | Placebo comparator | A SAD part in Chinese healthy adult subjects or overweight or obese adults but otherwise healthy adult subjects. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Safety and Tolerability
Area under the serum concentration-time curve (AUC). For Part 1 and Part 3, AUC from time 0 to infinity (AUC0-inf) is presented. For Part 2, AUC over the dosing interval (AUC0-tau) assessed from pre-dose on Day 78 to 168 hours post-dose is presented. Data presented are from baseline through Day 29 (Part 1 and Part 3) and from pre-final dose on Day 78 through Day 106 (Part 2)
Measured: Baseline through Day 29 (Part 1 & Part 3); Pre-final dose on Day 78 through Day 106 (Part 2)
Secondary outcomes (30)
Area Under the Serum Concentration Versus Time Curve (AUC)
The area under the serum concentration versus time curve from Time 0 to Time t (AUC0-t), which is calculated over the following time frames: baseline through Day 29 for Part 1 and Part 3; for Part 2, from pre-dose of the final dose on Day 78 to post-dose Day 106 (Day 29 after the final dose).
Measured: baseline through day 29 (part 1and part 3)or day 106 (part 2)
Maximum Observed Serum Concentration (Cmax)
Maximum observed serum concentration (Cmax). For Part 1 and Part 3, data are presented from baseline through Day 29. For Part 2, data after the final dose (administered on Day 78) are presented through Day 106. The time frame for data collection spans the entire study period for each part as indicated.
Measured: baseline through day 29 (part 1and part 3) or day 106 (part 2)
Time to Reach Maximum Observed Serum Concentration (Tmax)
Maximum observed serum concentration (Cmax). For Part 1 and Part 3, data are presented from baseline through Day 29. For Part 2, data after the final dose (administered on Day 78) are presented through Day 106. The time frame for data collection spans the entire study period for each part as indicated.
Measured: baseline through day 29 (part 1and part 3) or day 106 (part 2).
Terminal Elimination Half-life (t1/2)
Maximum observed serum concentration (Cmax). For Part 1 and Part 3, data are presented from baseline through Day 29. For Part 2, data after the final dose (administered on Day 78) are presented through Day 106. The time frame for data collection spans the entire study period for each part as indicated.
Measured: baseline through day 29 (part 1and part 3) or day 106 (part 2).
Apparent Clearance After Extravascular Administration (CL/F)
Maximum observed serum concentration (Cmax). For Part 1 and Part 3, data are presented from baseline through Day 29. For Part 2, data after the final dose (administered on Day 78) are presented through Day 106. The time frame for data collection spans the entire study period for each part as indicated.
Measured: baseline through day 29 (part 1and part 3) or day 106 (part 2)
Apparent Volume of Distribution During the Terminal Elimination Phase After Extravascular Administration (Vz/F)
Maximum observed serum concentration (Cmax). For Part 1 and Part 3, data are presented from baseline through Day 29. For Part 2, data after the final dose (administered on Day 78) are presented through Day 106. The time frame for data collection spans the entire study period for each part as indicated.
Measured: baseline through day 29 (part 1and part 3) or day 106 (part 2)
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-inf)
Measured: baseline through day29(part 1 and part 3 )
Change in Body Weight
the difference in LS Means body weight change from baseline compared with placebo
Measured: baseline through Day 85(part 2)
Change in Adiponectin
the difference in LS Means adiponectin change from baseline compared with placebo
Measured: baseline through Day 85
the Difference in LS Means BMI Change From Baseline Compared With Placebo
change in BMI
Measured: baseline through Day 85(part 2)
the Difference in LS Means Waist Circumference Change From Baseline Compared With Placebo
change in waist circumference
Measured: baseline through Day 85(part 2)
Change in Fasting Lipid Profile
the difference in LS Means Ratio fasting lipid profile change from baseline compared with placebo
Measured: baseline through Day 85（part 2）
Change in Fasting Plasma Glucose (FPG)
the difference in LS Means FPG change from baseline compared with placebo
Measured: baseline through Day 85
Change in C-peptide
the difference in LS Means Ratio of C-peptide change from baseline compared with placebo
Measured: baseline through Day 85（part 2）
Change in Fasting Insulin
the difference in LS Means Ratio of fasting insulin change from baseline compared with placebo
Measured: baseline through Day 85（part 2）
Change in Hemoglobin A1C
the difference in LS Means Ratio of Hemoglobin A1C change from baseline compared with placebo
Measured: baseline through Day 85（part 2）
Change in Glucagon
the difference in LS Means Ratio fasting glucagon change from baseline compared with placebo
Measured: baseline through Day 85
Change in Homeostatic Model Assessment Index of Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment Index of Beta-cell Function (HOMA-B)
The difference in LS Means Ratio HOMA-IR and HOMA-B change from baseline compared with placebo. HOMA-IR: (Fasting Insulin [μU/mL] × Fasting Glucose [mmol/L]) / 22.5; HOMA-β: (20 × Fasting Insulin [μU/mL]) / (Fasting Glucose [mmol/L] - 3.5). For HOMA-IR: lower values indicate improved insulin sensitivity (less insulin resistance), representing a better outcome. For HOMA-B: higher values indicate enhanced pancreatic beta-cell function, representing a better outcome.
Measured: baseline through Day 85
Percent Change From Baseline in Hepatic Fat Fraction Measured by MRI-PDFF in Part 2
percentage change from baseline in hepatic fat fraction measured by MRI-PDFF in part 2. Percent change was calculated as [(post-baseline value - baseline value) / baseline value] × 100.
Measured: Baseline (screening) and Day 85 to Day 99 in Part 2
Positive Rate of ADA
overall positive rate of ADA at EOS
Measured: from baseline to the end of the study, up to Day29s (part1, part3), up to Day106s (part2)
Continuous Glucose Monitoring Outcome
Individual results of CGM endpoints and results are presented by subject in the listing contained in the CSR attachment.
Measured: from baseline to D79（part 2）
Change in Fibrosis 4 Index
Change in Fibrosis 4 Index from baseline. Fibrosis 4 Index (FIB-4) is a continuous calculated score for liver fibrosis staging, derived from the formula: FIB-4 = (age [years] × AST [U/L]) / (platelet count [10^9/L] × √ALT [U/L]), which can be used to identify patients with a low probability of advanced fibrosis. The theoretical minimum value is 0, and there is no predefined maximum value (the score is open-ended). Lower values indicate a lower probability of advanced liver fibrosis, representing a better outcome. For clinical interpretation, commonly used cutoff values are as follows: FIB-4 < 1.3: low probability of advanced liver fibrosis (better outcome); 1.3 ≤ FIB-4 < 3.25: indeterminate fibrosis stage; FIB-4 ≥ 3.25: high probability of advanced liver fibrosis (worse outcome).
Measured: from baseline to D85（part 2）
Change in Non-Alcoholic Fatty Liver Disease Fibrosis Score
The Non-Alcoholic Fatty Liver Disease Fibrosis Score (NFS) is a derived non-invasive fibrosis score calculated as -1.675 + 0.037 × age (year) + 0.094 × BMI (kg/m^2) + 1.13 × impaired fasting glucose or diabetes (yes=1, no=0) + 0.99 × AST/ALT ratio - 0.013 × platelet count (×10^9/L) - 0.66 × albumin (g/dL). This score does not have a fixed theoretical minimum or maximum; higher values indicate greater likelihood of advanced fibrosis
Measured: from baseline to D85 (part 2)
Change in Alanine Aminotransferase
change in Alanine Aminotransferase from baseline
Measured: from baseline to D85 (part 2)
Change in Aspartate Aminotransferase
change in Aspartate Aminotransferase from baseline
Measured: from baseline to D85 (part 2)
Change in Partial Area Glucose Levels Versus Time Curve From Time 0 to 4 Hours (△AUC0-4h)
change in Partial area glucose levels versus time curve from time 0 to 4 hours (△AUC0-4h) from baseline
Measured: from 0 to 4 hours on D79
Change in Partial Area Insulin Levels Versus Time Curve From Time 0 to 4 Hours (△AUC0-4h)
change in Partial area insulin levels versus time curve from time 0 to 4 hours (△AUC0-4h) from baseline
Measured: from 0 to 4 hours on D79
Change in Partial Area C-peptide Levels Versus Time Curve From Time 0 to 4 Hours (△AUC0-4h)
change in Partial area C-peptide levels versus time curve from time 0 to 4 hours (△AUC0-4h) from baseline
Measured: from 0 to 4 hours on D79
Change in Partial Area Glucagon Levels Versus Time Curve From Time 0 to 4 Hours (△AUC0-4h)
change in Partial area glucagon levels versus time curve from time 0 to 4 hours (△AUC0-4h) from baseline
Measured: from 0 to 4 hours on D79
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
statistical analysis of TIR, TAR, TBR, 24-hour mean glucose and glucose variability was not performed due to small sample size
Measured: baseline through Day 85（part 2）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start22 Jun 2022
- Primary completion10 Oct 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy, Obesity, MetabolicallyStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Doer Biologics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandra Cole, DHPharm, Principal investigator, New Zealand Clinical Research (NZCR)Yanshan Huang, PhD, Study chair, Zhejiang Doer Biologics Co., Ltd.Yongliang Fang, PhD, Study director, Zhejiang Doer Biologics Co., Ltd.Junfang Xu, MD, Study director, Huadong Medicine Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378893
- Sponsor's protocol ID
- DR10624-101
- Status last verified
- May 2026
- First submitted
- 25 Mar 2022
- Last updated
- 19 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No