Overweight or ObesityPhase 2NCT07020884
A Study of ZT002 Injection With Subjects With Overweight or Obesity
A Phase 2 study testing ZT002 Injection in people with Overweight or Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 16 sites in China.
Trial summary
This study will evaluate the percentage change from baseline in weight after 24 weeks of treatment with ZT002 Injection in subjects with overweight/obesity. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 303 participants
- Where
- 16 sitesChina
- Study dates
- 14 Aug 2024to 29 May 2025
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 75 years.
- BMI ≥28 kg/m², or 24 kg/m2 ≤ BMI < 28 kg/m2 with at least one comorbidity (pre-diabetes, hypertension, hyperlipidemia, fatty liver, obstructive sleep apnoea syndrome due to overweight, weight-bearing joint pain, etc.)
- Weight change is not more than 5% with diet and exercise control alone within 3 months prior to screening.
Who cannot join
- Previous diagnosis of diabetes; or HbA1c ≥ 6. 5% or fasting blood glucose ≥ 7.0 mmol/L at screening.
- Have used medicines or treatments that affect weight within 3 months prior to screening.
- History of acute or chronic pancreatitis.
- Personal or family (parents, children, and siblings) history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type II (MEN2).
- History of definite mental disease within 2 years prior to screening or prior suicidal tendency or suicidal behavir; or PHQ-9 scale score is ≥ 15 at screening; or C-SSRS questionnaire is either class 4 or 5 at screening.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Peking University First Hospital
Beijing, 100044
Peking University People's Hospital
Beijing, 100044
Handan First Hospital
Handan, Hebei, 056002
The Fourth Affiliated Hospital Harbin Medical University
Harbin, Heilongjiang, 150001
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250000
Hebei Petro China Cental Hospital
Langfang, Hebei, 065000
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471000
Luoyang Third People's Hospital
Luoyang, Henan, 471002
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 210000
The First Affiliated of Nanyang Medical College
Nanyang, Henan, 473000
Genertec Liaoyou Gem Flower Hospital
Panjin, Liaoning, 124000
First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000
Tonghua Central Hospital
Tonghua, Jilin, 134000
Xi'an Daxing Hospital
Xi’an, Shanxi, 710000
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000
Zibo Municipal Hospital
Zibo, Shandong, 255400
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of ZT002 Injection in Subjects With Overweight or Obesity
This study will evaluate the percentage change from baseline in weight after 24 weeks of treatment with ZT002 Injection in subjects with overweight/obesity.
- Conditions
- Overweight or Obesity
- Being tested
- ZT002 Injection, ZT002 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
Administered SC
ZT002 PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| ZT002 Injection dose 1 | Experimental | Dose 1 administered subcutaneously (SC), Q2W Receives: Drug: ZT002 Injection |
| ZT002 Injection dose 2 | Experimental | Dose 2 administered subcutaneously (SC),Q2W Receives: Drug: ZT002 Injection |
| ZT002 Injection dose 3 | Experimental | Dose 3 administered subcutaneously (SC),Q4W Receives: Drug: ZT002 Injection |
| ZT002 Injection dose 4 | Experimental | Dose 4 administered subcutaneously (SC), Q4W Receives: Drug: ZT002 Injection |
| ZT002 Placebo | Placebo comparator | administered subcutaneously (SC), Q2W or Q4W Receives: Drug: ZT002 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change from baseline in weight after 24 weeks of treatment.
Measured: baseline, 24 weeks
Secondary outcomes (1)
The proportion of subjects with weight loss of ≥ 5%, ≥ 10%, and ≥ 15% from baseline after 24 weeks of treatment;
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start14 Aug 2024
- Primary completion7 May 2025
- Study completion29 May 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linong Ji, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020884
- Sponsor's protocol ID
- BJQL-ZT002-2001
- Status last verified
- Dec 2025
- First submitted
- 6 Jun 2025
- Last updated
- 10 Dec 2025
- 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 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of ZT002 Injection in Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07020884
- Acronym / sponsor ID
- BJQL-ZT002-2001
- Conditions
- Overweight or Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Beijing QL Biopharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 13 Jun 2025 (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 evaluate the percentage change from baseline in weight after 24 weeks of treatment with ZT002 Injection in subjects with overweight/obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ZT002 Injection dose 1 | Experimental | Drug: ZT002 InjectionDose 1 administered subcutaneously (SC), Q2W |
| ZT002 Injection dose 2 | Experimental | Drug: ZT002 InjectionDose 2 administered subcutaneously (SC),Q2W |
| ZT002 Injection dose 3 | Experimental | Drug: ZT002 InjectionDose 3 administered subcutaneously (SC),Q4W |
| ZT002 Injection dose 4 | Experimental | Drug: ZT002 InjectionDose 4 administered subcutaneously (SC), Q4W |
| ZT002 Placebo | Placebo comparator | Drug: ZT002 Placeboadministered subcutaneously (SC), Q2W or Q4W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years and ≤ 75 years.
- BMI ≥28 kg/m², or 24 kg/m2 ≤ BMI < 28 kg/m2 with at least one comorbidity (pre-diabetes, hypertension, hyperlipidemia, fatty liver, obstructive sleep apnoea syndrome due to overweight, weight-bearing joint pain, etc.)
- Weight change is not more than 5% with diet and exercise control alone within 3 months prior to screening.
Key exclusion criteria (5 listed)
- Previous diagnosis of diabetes; or HbA1c ≥ 6. 5% or fasting blood glucose ≥ 7.0 mmol/L at screening.
- Have used medicines or treatments that affect weight within 3 months prior to screening.
- History of acute or chronic pancreatitis.
- Personal or family (parents, children, and siblings) history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type II (MEN2).
- History of definite mental disease within 2 years prior to screening or prior suicidal tendency or suicidal behavir; or PHQ-9 scale score is ≥ 15 at screening; or C-SSRS questionnaire is either class 4 or 5 at screening.
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 InjectionAdministered SC | Drug | ZT002 Injection dose 1, ZT002 Injection dose 2, ZT002 Injection dose 3, ZT002 Injection dose 4 |
| ZT002 PlaceboAdministered SC | Drug | ZT002 Placebo |
Primary outcome
The percentage change from baseline in weight after 24 weeks of treatment.
Time frame: baseline, 24 weeks
1 secondary outcome
The proportion of subjects with weight loss of ≥ 5%, ≥ 10%, and ≥ 15% from baseline after 24 weeks of treatment;
Time frame: 24 weeks
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 10 Dec 2025.
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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.
Linong Ji, MD principal investigator
Peking University People's Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZT002 Injection in people with Overweight or Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 16 sites 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 3 inclusion and 5 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The percentage change from baseline in weight after 24 weeks of treatment. (time frame: baseline, 24 weeks). 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 10 Dec 2025.