Overweight or ObesityPhase 1NCT06371326
A Study of ZT002 Injection in Participants With Overweight or Obesity
A Phase 1 study testing ZT002 Injection in people with Overweight or Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 1 site in China.
Trial summary
This study will comprise a randomized, double-blind, placebo-controlled, multiple-ascending-dose, safety, tolerability, and pharmacokinetics study of ZT002 in participants with Overweight or Obesity. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- ZT002 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2023to 17 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Males and females aged 18 to 50 years (inclusive, based on age at the time of signing the informed consent form);
- 2. BMI ≥ 24 kg/m2 and < 28 kg/m2 with at least one of the following concomitant disease (pre-diabetes [except for type 1 or type 2 diabetes], hypertension, hyperlipidemia, fatty liver, obstructive sleep apnoea syndrome, weight-bearing joint pain, etc., see Appendices I and II) or BMI ≥ 28 kg/m2 and ≤ 40 kg/m2 and with or without concomitant disease;
- 3. Weight change of no more than 5% (based on self-report) after 3 months of weight control via diet and exercise alone prior to screening, and the formula for calculating weight change is: (highest weight - lowest weight during 3 months of weight control via diet and exercise alone prior to screening) ∕highest weight100%;
- 4. Female subjects are required to adopt abstinence or 2 effective methods of contraception from 1 month prior to screening to 6 months after the last dose, and male subjects are required to adopt abstinence or 2 effective methods of contraception from the first dose to 3 months after the last dose. For male subjects, the effective methods of contraception are as follows: surgical sterilization (e.g., vasectomy) or proper use of condoms, or the female partners use hormonal contraceptives (e.g., contraceptive pills, patches, implantable or injectable) or intrauterine devices (IUDs) or surgical sterilization; for female subjects, the effective methods of contraception are as follows: surgical sterilization (e.g., tubal ligation) or use of IUDs, or male partners properly use condoms or are surgically sterilized, in addition, the female subjects are allowed to use the NMPA-approved hormonal contraceptives (e.g., contraceptive pills, patches, implantable or injectable);
- 5. Subjects who have a good understanding of study objectives, be able to communicate well with the investigator, and be able to understand and comply with the requirements set forth for this study.
Who cannot join
- 1. History of specific allergies (asthma, eczema, etc.) or allergic constitution, or history of allergy to two or more drugs and foods, especially to the investigational drug and its excipients or GLP-1-containing drugs;
- 2. Previous diagnosis of obesity associated with endocrine disease or single gene mutation, including but not limited to, hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, hypogonadism;
- 3. Subjects who have had severe gastrointestinal diseases (e.g., active ulcers) or undergone gastrointestinal surgery (except for appendectomy or cholecystectomy) or have clinically significant abnormalities of gastric emptying (e.g., pyloric obstruction, gastric paralysis) within 6 months prior to screening or have been taking medications that have a direct effect on gastrointestinal motility for a long term, or who are not suitable for participation in the trial as assessed by the investigator;
- 4. Prior history of significant cardiovascular disease, defined as:
- History of myocardial infarction, coronary angioplasty or bypass grafting, heart valve disease or heart valve repair, clinically significant arrhythmia requiring treatment, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident within 6 months prior to screening; b) New York Heart Association (NYHA) class III or IV congestive cardiac failure;
- 5. Uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg;
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- 6. Laboratory test results at screening meet any of the following criteria (one retest is allowed during the screening period if there is any clear reason, and the investigator should document the reason for retest):
- Glycosylated hemoglobin (HbA1c) ≥ 6.5% or fasting plasma glucose ≥ 7.0 mmol/L, or two-hour plasma glucose ≥ 11.1 mmol/L on oral glucose tolerance test (OGTT) (at screening, subjects with fasting venous plasma glucose between 6.1 and 6.9 mmol/L need to perform OGTT) (see Appendix I, OGTT Test Method);
- Thyroid-stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 × ULN or blood total bilirubin ≥ 2 × ULN;
- Fasting triglycerides > 5.65 mmol/L;
- Blood amylase or blood lipase ≥ 1.5 × ULN;
- Calcitonin ≥ 50 ng/L (pg/mL);
- Estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m2, estimated using CKD-EPI formula (see Appendix 3);
- Abnormal 12-lead electrocardiogram (ECG): second- or third-degree atrioventricular block, long QT syndrome or QTcF > 450 ms (males) or > 470 ms (females) (see formula in Appendix 4), left or right bundle branch block, pre-excitation syndrome, or other clinically significant arrhythmia (except for sinus arrhythmia);
- 7. Previous history of acute and chronic pancreatitis, history of symptomatic gallbladder disease (except for cholecystectomy), history of pancreatic injury, and other high risk factors for pancreatitis;
- 8. Previous personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia syndrome (MEN2);
- 9. Prior diagnosis of malignancy (except for cured basal cell skin cancer or cervix carcinoma in situ);
- 10. A past history of hypoglycemia or recurrent symptomatic hypoglycemia (more than twice in 6 months);
- 11. Infectious disease (which would affect the subject's ability to participate in the trial as judged by the investigator) within 4 weeks prior to screening;
- 12. Use of any prescription, over-the-counter, or Chinese herbal medications within 1 month prior to screening or discontinuation less than 5 drug half-lives (whichever is longer);
- 13. Use of any of the following medications or therapies within 3 months prior to screening:
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- Any approved or unapproved weight-loss drugs (e.g., liraglutide, semaglutide, beinaglutide, orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion) or weight-affecting Chinese herbal medications, supplements, meal replacements;
- Use of any hypoglycemic medications (e.g., sodium-glucose cotransporter protein 2 inhibitors [SGLT2i] and glucagon-like peptide-1 receptor agonists [GLP-1RA], metformin, alpha-glucosidase inhibitors);
- Use of medications that may cause significant weight gain, including systemic glucocorticoid therapy; tricyclic antidepressants; antipsychotic or antiepileptic drugs (e.g., clomipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine hydrochloride, clozapine, olanzapine, valproic acid and its derivatives, lithium preparations, thioridazine), for more than 1 week;
- 14. Subject who have prior history of bariatric surgery (except for those who have undergone liposuction more than 1 year ago) or who plan to undergo bariatric surgery or use bariatric equipment during the study period;
- 15. Subjects who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the study, and anyone who has undergone surgery that affects drug absorption, distribution, metabolism, or excretion;
- 16. Subjects who have participated in other clinical trials and received drug therapies or medical device interventions within 3 months prior to screening;
- 17. Subjects who have been vaccinated within 1 month prior to screening or plan to be vaccinated during the trial;
- 18. Donation or loss of blood ≥ 400 mL, or blood transfusion within 3 months prior to screening;
- 19. Subjects who cannot tolerate blood collection by venipuncture or have a history of fainting during acupuncture and seeing blood;
- 20. Hepatitis B virus surface antigen (HbsAg) positive, or hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody (TP-Ab) positive at screening;
- 21. A history of alcohol abuse (drinking more than 14 units of alcohol per week [1 unit = 360 mL of beer with 5% alcohol, or 45 mL of spirits with 40% alcohol, or 150 mL of wine with 12% alcohol]) within 3 months prior to screening, subjects who have a positive alcohol breathalyzer test at baseline, or who are unable to abstain from alcohol during the study;
- 22. History of drug abuse within 3 months prior to screening or a positive drug abuse screening (urine screen);
- 23. Subjects who smoke ≥ 5 cigarettes per day within the 3 months prior to screening or who are unable to abstain from smoking throughout the study;
- 24. Significantly active or unstable major depression or other major psychiatric conditions or any history of suicide attempt within 2 years prior to screening;
- 25. Pregnant or lactating women;
- 26. Have other conditions that, in the judgment of the investigator, make participation in this study inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Phase Ic Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ZT002 Injection in Participants With Overweight or Obesity
This study will comprise a randomized, double-blind, placebo-controlled, multiple-ascending-dose, safety, tolerability, and pharmacokinetics study of ZT002 in participants with Overweight or Obesity.
- Conditions
- Overweight or Obesity
- Being tested
- ZT002 Injection, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZT002 InjectionDrug
Participants will receive ZT002 by subcutaneous (SC) injection.
PlaceboDrug
Participants will receive Placebo by subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| ZT002 Injection | Experimental | Participants will be randomized to receive ZT002 injection in 1of 2 dose cohorts. Receives: Drug: ZT002 Injection |
| ZT002 Placebo | Placebo comparator | Participants will be randomized to receive same volume Placebo in 1 of 2 dose cohorts. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of a multiple escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in MAD Cohorts. Number of participants with treatment-emergent adverse events.
Measured: up to 270 days
Safety and tolerability of a multiple escalation dose of ZT002 through the incidence severity of serious adverse events in MAD Cohorts. Number of participants with serious adverse events.
Measured: up to 270 days
Secondary outcomes (3)
The Pharmacokinetics (PK) profile of a multiple escalation dose of ZT002 in participants with overweight or obesity.
Parameter: Maximum observed plasma concentration of ZT002 (Css_max)
Measured: up to 270 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in participants with overweight or obesity.
Parameter: Area under the drug-time curve from 0 h after dosing to the last quantifiable concentration time point (AUC0-τ,SS)
Measured: up to 270 days
The anti-drug antibody (ADA) response through testing serum or plasma of the participants post-dosing.
Measured: up to 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start21 Nov 2023
- Primary completion15 Apr 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoli Li, Master, Principal investigator, The First Affiliated Hospital of Bengbu Medical UniversityHuan Zhou, PhD, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371326
- Sponsor's protocol ID
- BJQLZT002004
- Status last verified
- Jan 2026
- First submitted
- 10 Apr 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Phase Ic Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ZT002 Injection in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06371326
- Acronym / sponsor ID
- BJQLZT002004
- Conditions
- Overweight or Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will comprise a randomized, double-blind, placebo-controlled, multiple-ascending-dose, safety, tolerability, and pharmacokinetics study of ZT002 in participants with Overweight or Obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZT002 Injection | Experimental | Drug: ZT002 InjectionParticipants will be randomized to receive ZT002 injection in 1of 2 dose cohorts. |
| ZT002 Placebo | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive same volume Placebo in 1 of 2 dose cohorts. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Males and females aged 18 to 50 years (inclusive, based on age at the time of signing the informed consent form);
- 2. BMI ≥ 24 kg/m2 and < 28 kg/m2 with at least one of the following concomitant disease (pre-diabetes [except for type 1 or type 2 diabetes], hypertension, hyperlipidemia, fatty liver, obstructive sleep apnoea syndrome, weight-bearing joint pain, etc., see Appendices I and II) or BMI ≥ 28 kg/m2 and ≤ 40 kg/m2 and with or without concomitant disease;
- 3. Weight change of no more than 5% (based on self-report) after 3 months of weight control via diet and exercise alone prior to screening, and the formula for calculating weight change is: (highest weight - lowest weight during 3 months of weight control via diet and exercise alone prior to screening) ∕highest weight100%;
- 4. Female subjects are required to adopt abstinence or 2 effective methods of contraception from 1 month prior to screening to 6 months after the last dose, and male subjects are required to adopt abstinence or 2 effective methods of contraception from the first dose to 3 months after the last dose. For male subjects, the effective methods of contraception are as follows: surgical sterilization (e.g., vasectomy) or proper use of condoms, or the female partners use hormonal contraceptives (e.g., contraceptive pills, patches, implantable or injectable) or intrauterine devices (IUDs) or surgical sterilization; for female subjects, the effective methods of contraception are as follows: surgical sterilization (e.g., tubal ligation) or use of IUDs, or male partners properly use condoms or are surgically sterilized, in addition, the female subjects are allowed to use the NMPA-approved hormonal contraceptives (e.g., contraceptive pills, patches, implantable or injectable);
- 5. Subjects who have a good understanding of study objectives, be able to communicate well with the investigator, and be able to understand and comply with the requirements set forth for this study.
Key exclusion criteria (39 listed)
- 1. History of specific allergies (asthma, eczema, etc.) or allergic constitution, or history of allergy to two or more drugs and foods, especially to the investigational drug and its excipients or GLP-1-containing drugs;
- 2. Previous diagnosis of obesity associated with endocrine disease or single gene mutation, including but not limited to, hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, hypogonadism;
- 3. Subjects who have had severe gastrointestinal diseases (e.g., active ulcers) or undergone gastrointestinal surgery (except for appendectomy or cholecystectomy) or have clinically significant abnormalities of gastric emptying (e.g., pyloric obstruction, gastric paralysis) within 6 months prior to screening or have been taking medications that have a direct effect on gastrointestinal motility for a long term, or who are not suitable for participation in the trial as assessed by the investigator;
- 5. Uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg;
- 6. Laboratory test results at screening meet any of the following criteria (one retest is allowed during the screening period if there is any clear reason, and the investigator should document the reason for retest):
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 |
|---|---|---|
| ZT002 InjectionParticipants will receive ZT002 by subcutaneous (SC) injection. | Drug | ZT002 Injection |
| PlaceboParticipants will receive Placebo by subcutaneous (SC) injection. | Drug | ZT002 Placebo |
Primary outcome
Safety and tolerability of a multiple escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in MAD Cohorts. Number of participants with treatment-emergent adverse events.
Time frame: up to 270 days
Safety and tolerability of a multiple escalation dose of ZT002 through the incidence severity of serious adverse events in MAD Cohorts. Number of participants with serious adverse events.
Time frame: up to 270 days
3 secondary outcomes
The Pharmacokinetics (PK) profile of a multiple escalation dose of ZT002 in participants with overweight or obesity.
Time frame: up to 270 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in participants with overweight or obesity.
Time frame: up to 270 days
The anti-drug antibody (ADA) response through testing serum or plasma of the participants post-dosing.
Time frame: up to 270 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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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.
Xiaoli Li, Master principal investigator
The First Affiliated Hospital of Bengbu Medical University
Huan Zhou, PhD principal investigator
The First Affiliated Hospital of Bengbu Medical University
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 ZT002 Injection in people with Overweight or Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 1 site in China.
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 5 inclusion and 39 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 16 Jan 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of a multiple escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in MAD Cohorts. Number of participants with treatment-emergent adverse events. (time frame: up to 270 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.