AzTrials
AzTrials

Overweight , ObesityPhase 2NCT07230132

Efficacy and Safety of ZT006 in Overweight and Obese Participants

A Phase 2 study testing ZT006 in people with Overweight , Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 12 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is being conducted to evaluate the efficacy and safety of ZT006 tablet in participants with overweight and obesity. In addition to dietary caloric restriction and increased physical activity, study participants will receive either ZT006 tablets or placebo tablets once every morning (placebo looks like ZT006… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight , Obesity
What is being tested?
ZT006
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
184 participants
Where
12 sitesChina
Study dates
12 Dec 2025to 31 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age between 18 - 65 years (both inclusive) at the time of signing of the informed consent.
  • Body mass index (BMI) greater than or equal to 28 kg/m², or greater than or equal to 24 kg/m²with at least one of the comorbidities: hypertension, hyperlipidemia, pre-diabetes, metabolic dysfunction-associated steatotic liver disease (MASLD) or obstructive sleep apnea-hypopnea syndrome (OSAHS).
  • Having dietary caloric restriction and increased physical activity for ≥3 months, with change in body weight (increase or decrease) no more than 5%, irrespective of medical records.
  • Assigned to low/medium target dose groups in the main study and having completed week 28 visit in the main study
  • Administration of low/medium target dose ≥ 10 times in the last two weeks in the main study

Who cannot join

  • Type 1 or type 2 diabetes or other specific types derived from other causes
  • Medical history of acute or chronic pancreatitis
  • Medical history of cholecystitis, gallstone ≤1 cm, or history of symptomatic gallbladder diseases
  • Use of glucagon-like peptide-1 (GLP-1) agonist, dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) or GLP-1/glucagon agonist, or triple GLP-1/GIP/glucagon agonist within 90 days before screening
  • HbA1c ≥ 6.5% or fasting plasma glucose ≥ 7.0 mmol/L at screening
  • Triglyceride ≥ 5.7 mmol/L at screening
Show all 10Show fewer
  • Calcitonin ≥ 50 ng/L at screening
  • EXTENSION PERIOD:
  • Participation in the dense PK sampling in the main study
  • BMI ≤18.5 kg/m² at week 28 visit in the main study

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Peking University People's Hospital

    Beijing, 100044

  • The First People's Hospital of Chenzhou

    Chenzhou, Hunan

  • Handan First Hospital

    Handan, Hebei, 056002

  • Harbin Medical University Affiliated Fourth Hospital

    Harbin, Heilongjiang, 150001

  • Huzhou Central Hospital

    Huzhou, Zhejiang

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250000

  • Hebei Petro China Central Hospital

    Langfang, Hebei, 065000

  • Luoyang Third People's Hospital

    Luoyang, Henan, 471002

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210003

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Xi'an Daxing Hospital

    Xi’an, Shanxi, 710000

  • YueYang People's Hospital

    Yueyang, Hunan, 414022

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Various Doses of ZT006 in Overweight and Obese Participants

This study is being conducted to evaluate the efficacy and safety of ZT006 tablet in participants with overweight and obesity.

In addition to dietary caloric restriction and increased physical activity, study participants will receive either ZT006 tablets or placebo tablets once every morning (placebo looks like ZT006 tablets but has no active pharmaceutical ingredients). For a fair comparison, study participants are assigned to ZT006 or placebo randomly by a computer.

Read more

The study consists of a main study and an extension period. The treatment of the main study will last for 28 weeks. ZT006 tablets will be administered daily in an up-titration fashion, i.e. the dose of ZT006 will be gradually increased to reach three target doses (low, medium, high) so that the participants can tolerate its effect. Participants will have 17 clinic visits including one screening visit and one follow-up visit.

The extension study will be conducted only in participants assigned to the low and medium dose groups in the main study. The treatment of the extension period will be 12 weeks.

Female participants who are pregnant, breast-feeding or who plan to become pregnant during the study are not allowed to participate in the study. Pregnancy will be checked by blood or urine tests during the study.

Being tested
ZT006, Placebo of ZT006
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZT006Drug

    Participants will receive a daily dose of ZT006

  • Placebo of ZT006Drug

    Participants will receive a daily dose of placebo of ZT006

  • ZT006Drug

    Participants will receive a weekly dose of ZT006

  • ZT006Drug

    Participants will receive a weekly dose of ZT006

  • ZT006Drug

    Participants will receive a weekly dose of ZT006

  • ZT006Drug

    Participants will receive a weekly dose of ZT006

Study groups in NCT07230132
Study groupRoleWhat they receive
ZT006 tablet low target doseExperimentaladministered per os, daily
Receives: Drug: ZT006
ZT006 tablet medium target doseExperimentaladministered per os, daily
Receives: Drug: ZT006
ZT006 tablet high target doseExperimentaladministered per os, daily
Receives: Drug: ZT006
placebo of ZT006Placebo comparatoradministered per os, daily
Receives: Drug: Placebo of ZT006
ZT006 tablet weekly dose 1Experimentaladministered per os, weekly
Receives: Drug: ZT006
ZT006 tablet weekly dose 2Experimentaladministered per os, weekly
Receives: Drug: ZT006

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight relative to baseline

    Percentage-point

    Measured: Percentage-point from baseline to end of treatment (week 28)of the main study

  2. Rate of treatment-emergent adverse events in the extension period

    Summarized from adverse event reporting in %

    Measured: From week 28 to week 45

  3. Rate of serious adverse events in the extension period

    Summarized from adverse event reporting in %

    Measured: From week 28 to week 45

Secondary outcomes (11)

  1. Proportion of participants who achieved body weight reduction greater than or equal to 5% at week 28

    Proportion of participants in %

    Measured: From baseline to end of treatment in the main study (week 28)

  2. Proportion of participants who achieved body weight reduction greater than or equal to 10% at week 28

    Proportion of participants in %

    Measured: From baseline to end of treatment in the main study (week 28)

  3. Proportion of participants who achieved body weight reduction greater than or equal to 15% at week 28

    Proportion of participants in %

    Measured: From baseline to end of treatment in the main study(week 28)

  4. Change in body weight

    Measured in kg

    Measured: From baseline to end of treatment in the main study (week 28)

  5. Change in waist circumference

    Measured in cm

    Measured: From baseline to end of treatment in the main study (week 28)

  6. Change in body mass index (BMI)

    Measured in kg/m²（ Body weight in kilogram divided by the square of height in meter ）

    Measured: From baseline to end of treatment in the main study (week 28)

  7. Rate of treatment-emergent adverse events

    Summarized from adverse event reporting in %

    Measured: From baseline to end of the main study (week 33)

  8. Rate of serious adverse events

    Summarized from adverse event reporting in %

    Measured: From baseline to end of the main study (week 33)

  9. Proportion of participants with positive anti-ZT006 antibody

    Summarized in %

    Measured: From baseline to end of treatment in the main study (week 33)

  10. Change in body weight relative to baseline in the extension period

    Percentage point

    Measured: From week 28 to week 40

  11. Change in body weight

    Measured in kg

    Measured: From week 28 to week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2025
  2. Study start12 Dec 2025
  3. Primary completion12 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07230132
Sponsor's protocol ID
BJQL-ZT006-2001
Status last verified
Jun 2026
First submitted
13 Nov 2025
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZT006 in people with Overweight , Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 12 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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in body weight relative to baseline (time frame: Percentage-point from baseline to end of treatment (week 28)of the main study). The study lists 3 primary outcomes in all. 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 NCT07230132.

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 12 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in