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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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:

Show all 13Show fewer

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.

Show all 26Show fewer

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

Other trials in New Zealand

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 groups in NCT05378893
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.

22 Jun 202231 Jan 2025

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05378893
Acronym / sponsor ID: DR10624-101
Conditions: Healthy, Obesity, Metabolically
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Zhejiang Doer Biologics Co., Ltd.Industry (pharma, biotech, devices)
Study start: 22 Jun 2022 (actual)
Primary completion: 10 Oct 2024 (actual)
Study completion: 31 Jan 2025 (actual)
First posted: 18 May 2022 (actual)
Results: Posted 19 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Single-ascending dose：Part1：DR10624	Experimental	Drug: DR10624 for injectionEscalating doses of DR10624 for injection administered subcutaneously in healthy participants or obese but otherwise healthy participants
Single-ascending dose：Part1：placebo	Placebo comparator	Drug: PlaceboEscalating doses of placebo for injection administered subcutaneously in in healthy participants or obese but otherwise healthy participants
Multiple-ascending dose：Part2：DR10624	Experimental	Drug: DR10624 for injectionEscalating doses of DR10624 for injection administered subcutaneously in obese adult subjects with moderate hypertriglyceridemia
Multiple-ascending dose：Part2：placebo	Placebo comparator	Drug: PlaceboEscalating doses of placebo for injection administered subcutaneously in obese adult subjects with moderate hypertriglyceridemia
Single-ascending dose：Part3：DR10624	Experimental	Drug: DR10624 for injectionA SAD part in Chinese healthy adult subjects or overweight or obese adults but otherwise healthy adult subjects.
Single-ascending dose：Part3：placebo	Placebo comparator	Drug: PlaceboA SAD part in Chinese healthy adult subjects or overweight or obese adults but otherwise healthy adult subjects.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

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.

Key exclusion criteria (26 listed)

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.

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
DR10624 for injectionadministered via subcutaneous injection	Drug	Multiple-ascending dose：Part2：DR10624, Single-ascending dose：Part1：DR10624, Single-ascending dose：Part3：DR10624
Placeboadministered via subcutaneous injection	Drug	Multiple-ascending dose：Part2：placebo, Single-ascending dose：Part1：placebo, Single-ascending dose：Part3：placebo

Primary outcome

Assess the Safety and Tolerability
Time frame: Baseline through Day 29 (Part 1 & Part 3); Pre-final dose on Day 78 through Day 106 (Part 2)
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)

30 secondary outcomes

Area Under the Serum Concentration Versus Time Curve (AUC)
Time frame: baseline through day 29 (part 1and part 3)or day 106 (part 2)
Maximum Observed Serum Concentration (Cmax)
Time frame: baseline through day 29 (part 1and part 3) or day 106 (part 2)
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time frame: baseline through day 29 (part 1and part 3) or day 106 (part 2).
Terminal Elimination Half-life (t1/2)
Time frame: baseline through day 29 (part 1and part 3) or day 106 (part 2).
Apparent Clearance After Extravascular Administration (CL/F)
Time frame: 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)
Time frame: 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)
Time frame: baseline through day29(part 1 and part 3 )
Change in Body Weight
Time frame: baseline through Day 85(part 2)
Change in Adiponectin
Time frame: baseline through Day 85
the Difference in LS Means BMI Change From Baseline Compared With Placebo
Time frame: baseline through Day 85(part 2)
the Difference in LS Means Waist Circumference Change From Baseline Compared With Placebo
Time frame: baseline through Day 85(part 2)
Change in Fasting Lipid Profile
Time frame: baseline through Day 85（part 2）
Change in Fasting Plasma Glucose (FPG)
Time frame: baseline through Day 85
Change in C-peptide
Time frame: baseline through Day 85（part 2）
Change in Fasting Insulin
Time frame: baseline through Day 85（part 2）
Change in Hemoglobin A1C
Time frame: baseline through Day 85（part 2）
Change in Glucagon
Time frame: 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)
Time frame: baseline through Day 85
Percent Change From Baseline in Hepatic Fat Fraction Measured by MRI-PDFF in Part 2
Time frame: Baseline (screening) and Day 85 to Day 99 in Part 2
Positive Rate of ADA
Time frame: from baseline to the end of the study, up to Day29s (part1, part3), up to Day106s (part2)
Continuous Glucose Monitoring Outcome
Time frame: from baseline to D79（part 2）
Change in Fibrosis 4 Index
Time frame: from baseline to D85（part 2）
Change in Non-Alcoholic Fatty Liver Disease Fibrosis Score
Time frame: from baseline to D85 (part 2)
Change in Alanine Aminotransferase
Time frame: from baseline to D85 (part 2)
Change in Aspartate Aminotransferase
Time frame: from baseline to D85 (part 2)
Change in Partial Area Glucose Levels Versus Time Curve From Time 0 to 4 Hours (△AUC0-4h)
Time frame: from 0 to 4 hours on D79
Change in Partial Area Insulin Levels Versus Time Curve From Time 0 to 4 Hours (△AUC0-4h)
Time frame: 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)
Time frame: from 0 to 4 hours on D79
Change in Partial Area Glucagon Levels Versus Time Curve From Time 0 to 4 Hours (△AUC0-4h)
Time frame: 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
Time frame: baseline through Day 85（part 2）

Results and safety

Results posted to the registry on 19 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single-ascending Dose：Part1：DR10624 0.5mg	4	4
Single-ascending Dose：Part1：DR10624 1.5mg	6	6
Single-ascending Dose：Part1：DR10624 4.5mg	6	6
Single-ascending Dose：Part1：DR10624 12.5mg	6	6
Single-ascending Dose：Part1：DR10624 25mg	6	6
Single-ascending Dose：Part1：DR10624 50mg	6	6
Single-ascending Dose：Part1：DR10624 65mg	6	6
Single-ascending Dose：Part1：DR10624 90mg	6	6
Single-ascending Dose：Part1：DR10624 120mg	6	6
Single-ascending Dose：Part1：Placebo	16	16
Multiple-ascending Dose：Part2：DR10624 12.5mg	10	9
Multiple-ascending Dose：Part2：DR10624 25mg	10	9
Multiple-ascending Dose：Part2：DR10624 50mg	11	8
Multiple-ascending Dose：Part2：DR10624 75mg	10	8
Multiple-ascending Dose：Part2：Placebo	8	7
Single-ascending Dose：Part3：DR10624 65mg	10	10
Single-ascending Dose：Part3：DR10624 90mg	10	10
Single-ascending Dose：Part3：DR10624 25mg	10	10
Single-ascending Dose：Part3：Placebo	6	6

Primary outcome: Assess the Safety and Tolerability

Time frame: Baseline through Day 29 (Part 1 & Part 3); Pre-final dose on Day 78 through Day 106 (Part 2). Number. Unit: participants

Measure	DR10624 0.5mg Part1 n = 4	DR10624 1.5mg part1 n = 6	DR10624 4.5mg part1 n = 6	DR10624 12.5mg part1 n = 6	DR10624 25mg part1 n = 6	DR10624 50mg part1 n = 6	DR10624 65mg part1 n = 6	DR10624 90mg part1 n = 6	DR10624 120mg part1 n = 6	Single-ascending Dose：Part1：Placebo n = 16	DR10624 12.5mg Part2 n = 10	DR10624 25mg part2 n = 10	DR10624 50mg part2 n = 11	DR10624 75mg part2 n = 10	Multiple-ascending Dose：Part2：Placebo n = 8	DR10624 25mg Part 3 n = 10	DR10624 65mg part3 n = 10	DR10624 90mg part3 n = 10	Single Ascending Dose :Part 3:Placebo n = 6
Any TEAE: Any TEAE	4	5	4	6	5	6	6	5	5	12	10	10	11	10	7	7	6	7	5
Any Treatment-Related TEAE: Any TEAE	0	1	2	3	3	6	6	4	4	4	6	8	11	10	5	5	3	7	0

Population analysed: Safety Analysis Set

30 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollment until end of follow-up, part1 up to 29 days, part2 up to 106 days, part3 up to 29 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-ascending Dose：Part1：DR10624 0.5mg	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Single-ascending Dose：Part1：DR10624 1.5mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Single-ascending Dose：Part1：DR10624 4.5mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Single-ascending Dose：Part1：DR10624 12.5mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Single-ascending Dose：Part1：DR10624 25mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Single-ascending Dose：Part1：DR10624 50mg	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Single-ascending Dose：Part1：DR10624 65mg	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Single-ascending Dose：Part1：DR10624 90mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Single-ascending Dose：Part1：DR10624 120mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Single-ascending Dose：Part1：Placebo	1 of 16 (6.3%)	1 of 16 (6.3%)	0 of 16
Multiple-ascending Dose：Part2：DR10624 12.5mg	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Multiple-ascending Dose：Part2：DR10624 25mg	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Multiple-ascending Dose：Part2：DR10624 50mg	0 of 11 (0%)	11 of 11 (100%)	0 of 11
Multiple-ascending Dose：Part2：DR10624 75mg	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Multiple-ascending Dose：Part2：Placebo	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Single-ascending Dose：Part 3：DR10624 25mg	0 of 10 (0%)	3 of 10 (30%)	0 of 10
Single-ascending Dose：Part 3：DR10624 65mg	0 of 10 (0%)	6 of 10 (60%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 26 exclusion criteria. 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in New Zealand. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 19 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Assess the Safety and Tolerability (time frame: Baseline through Day 29 (Part 1 & Part 3); Pre-final dose on Day 78 through Day 106 (Part 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05378893.

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 19 Oct 2026.