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Overweight,ObesityPhase 1NCT07307638

Dose-escalation and Food Effect Study of ZT006 in Healthy, Overweight and Obese Participants

A Phase 1 study testing ZT006 in people with Overweight,Obesity, run by Beijing QL Biopharmaceutical Co.,Ltd at 1 site in China.

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

ZT006 is an oral, long-acting glucagon-like peptide-1. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZT006 in healthy, overweight and obese participants. The study comprises three parts, i.e. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
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
94 participants
Where
1 siteChina
Study dates
28 Nov 2024to 24 Jun 2025
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, 12-lead electrocardiogram and clinical laboratory tests (hematology, urinalysis, chemistry, coagulation), as judged by the investigator.
  • Male or female, age between 18 - 55 years (both inclusive) at the time of signing of the informed consent.
  • Body mass index (BMI) 19.0 - 35.0 kg/m²(both inclusive). Body weight >50.0 kg for male participants and >45.0 kg for female participants. BMI 19 - 28.0 kg/m²(both inclusive) for single-dose escalation study, BMI 19.0 - 28.0 kg/m²(both inclusive) for cohorts 1 and 2 of multiple-dose escalation study, BMI 24.0 - 35.0 kg/m²(both inclusive) for cohorts 3 and 4 of multiple-dose escalation study.
  • 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.

Who cannot join

  • Known hypersensitivity to the study drug or excipients or GLP-1 receptor agonists.
  • Medical history of hypoglycemia.
  • History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or history of pancreatitis or symptomatic gallbladder disease.
  • Previous diagnosis of endocrine disorders or monogenic mutations causing obesity, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroidism-induced obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism.
  • Use of GLP-1 receptor agonists within 30 days or 5 half-lives (whichever is longer) before the first dose of the investigational intervention.
  • Glycated hemoglobin (HbA1c) > 6.0% or fasting plasma glucose < 3.9 mmol/L or > 6.1 mmol/L at screening, or diagnosed with diabetes mellitus of type 1 or type 2 diabetes or other specific types derived from other causes.
Show all 11Show fewer
  • Aspartate aminotransferase ≥ 2 × upper limit of normal (ULN), Alanine aminotransferase ≥ 2 × ULN, or total bilirubin ≥ 1.5 × ULN
  • Calcitonin above ULN at screening.
  • Other clinically significant diseases detected within 12 months before screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular diseases).
  • Use of prescription drugs (excluding topical eye/nose drops and creams without systemic exposure risk), over-the-counter drugs, dietary supplements, vitamins, or herbal medicines (excluding routine vitamins) within 2 weeks before screening.
  • Long-term use of medications directly affecting gastrointestinal motility prior to screening. Use of weight-loss medications (including but not limited to orlistat) within 3 months before dosing.

Trial locations and contacts

1 site in 1 country.

China1 site
  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ZT006 as Well as the Food Effect on the Pharmacokinetics of ZT006 in Healthy, Overweight and Obese Participants

ZT006 is an oral, long-acting glucagon-like peptide-1. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZT006 in healthy, overweight and obese participants. The study comprises three parts, i.e. single dose-escalation, multiple dose-escalation, food effect on the pharmacokinetics of ZT006.

In the single dose-escalation study, participants will receive a single dose (ZT006 dose level 1 - 5 or corresponding placebo) of ZT006 under fasted condition. A higher dose can only be given after obtaining acceptable safety and tolerability data for at least 7 days after the previous dose. After study drug administration, there will be a 7-day in-house period for safety observation and pharmacokinetics samples collection. Participants will join ambulatory visits until 42 days post-dose.

Read more

In the multiple dose-escalation study, participants will receive a daily dose of ZT006 or corresponding placebo over 42 days in a dose up-titration fashion according to the following regimen:

  • Cohort 1: dose level 1 - dose level 2 - dose level 3
  • Cohort 2: dose level 1 - dose level 2 - dose level 3 - dose level 4
  • Cohort 3: dose level 2 - dose level 3 - dose level 4
  • Cohort 4: dose level 2 - dose level 3 - dose level 4 - dose level 5

Dosing of a cohort with higher drug exposure can only be done after evaluation of safety and tolerability data for at least 14 days after the first dose in the previous cohort. Participants will join ambulatory visits until 35 days after the last dose.

To evaluate the food effect on the pharmacokinetics of ZT006, participants who have received single dose of ZT006 or placebo of dose level 4 in the single dose-escalation study will receive another dose of ZT006 or placebo after a high fat, high caloric breakfast.

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 single dose of ZT006 of dose level 1 under fasted condition.

  • ZT006Drug

    Participants will receive a single dose of ZT006 of dose level 2 under fasted condition.

  • ZT006Drug

    Participants will receive a single dose of ZT006 of dose level 3 under fasted condition.

  • ZT006Drug

    Participants will receive a single dose of ZT006 of dose level 4 under fasted condition in period 1, and after a high fat, high caloric breakfast in period 2.

  • ZT006Drug

    Participants will receive a single dose of ZT006 of dose level 5 under fasted condition.

  • ZT006Drug

    Participants will receive daily doses of ZT006 for 42 days: dose level 1 for 7 days, then dose level 2 for 7 days, then dose level 3 for 28 days.

  • ZT006Drug

    Participants will receive daily doses of ZT006 for 42 days: dose level 1 for 7 days, then dose level 2 for 7 days, then dose level 3 for 14 days, then dose level 4 for 14 days.

  • ZT006Drug

    Participants will receive daily doses of ZT006 for 42 days: dose level 2 for 7 days, then dose level 3 for 7 days, then dose level 4 for 28 days.

  • ZT006Drug

    Participants will receive daily doses of ZT006 for 42 days: dose level 2 for 7 days, then dose level 3 for 7 days, then dose level 4 for 14 days, then dose level 5 for 14 days.

  • Placebo of ZT006Drug

    Participants will receive a single dose of placebo of ZT006 under fasted condition.

  • Placebo of ZT006Drug

    Participants will receive a single dose of placebo of ZT006 under fasted condition in period 1, and after a high fat, high caloric breakfast in period 2.

  • Placebo of ZT006Drug

    Participants will receive daily doses of placebo of ZT006 for 42 days.

Study groups in NCT07307638
Study groupRoleWhat they receive
ZT006 tablet, dose level 1, single dose, fastedExperimentalNot described
Receives: Drug: ZT006
ZT006 tablet, dose level 2, single dose, fastedExperimentalNot described
Receives: Drug: ZT006
ZT006 tablet, dose level 3, single dose, fastedExperimentalNot described
Receives: Drug: ZT006
ZT006 tablet, dose level 4, single dose, fasted and fedExperimentalNot described
Receives: Drug: ZT006
ZT006 tablet, dose level 5, single dose, fastedExperimentalNot described
Receives: Drug: ZT006
ZT006 tablet, multiple doses, cohort 1ExperimentalNot described
Receives: Drug: ZT006
ZT006 tablet, multiple doses, cohort 2ExperimentalNot described
Receives: Drug: ZT006
ZT006 tablet, multiple doses, cohort 3ExperimentalNot described
Receives: Drug: ZT006
ZT006 tablet, multiple doses, cohort 4ExperimentalNot described
Receives: Drug: ZT006
placebo of ZT006, single dose, fastedPlacebo comparatorNot described
Receives: Drug: Placebo of ZT006
placebo of ZT006, single dose, fasted and fedPlacebo comparatorNot described
Receives: Drug: Placebo of ZT006
placebo of ZT006, multiple dosesPlacebo comparatorNot described
Receives: Drug: Placebo of ZT006

What is being measured

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

  1. Rate of treatment-emergent adverse events after single dose administration under fasted condition.

    Summarized from adverse event reporting in %

    Measured: From baseline to Day 43

  2. Rate of treatment-emergent adverse events during and after multiple-dose administration.

    Summarized from adverse event reporting in %

    Measured: From baseline to end of study (Day 77)

  3. Rate of treatment-emergent adverse events after single dose administration under fed condition.

    Summarized from adverse event reporting in %

    Measured: From Day 44 to end of study (Day 86)

Secondary outcomes (14)
  1. Area under the concentration-time curve from time zero to infinity after single-dose administration under fasted condition.

    Measured in ng*h/mL

    Measured: From baseline to Day 43

  2. Maximal observed concentration after single-dose administration under fasted condition.

    Measured in ng/mL

    Measured: From baseline to Day 43

  3. Time to reach the maximal observed concentration after single-dose administration under fasted condition.

    Measured in hours

    Measured: From baseline to Day 43

  4. Terminal half-life after single-dose administration under fasted condition.

    Measured in hours

    Measured: From baseline to Day 43

  5. Area under the concentration-time curve during the dosing interval at steady state.

    Measured in ng*h/mL

    Measured: Day 42 to Day 77

  6. Maximal observed concentration at steady state.

    Measured in ng/mL

    Measured: Day 42 to Day 77

  7. Time to reach the maximal observed concentration at steady state.

    Measured in hours

    Measured: From Day 42 to Day 77

  8. Terminal half-life at steady state.

    Measured in hours

    Measured: From Day 42 to Day 77

  9. Area under the concentration-time curve from time zero to infinity after single-dose administration under fed condition.

    Measured in ng*h/mL

    Measured: From Day 44 to end of study (Day 86)

  10. Maximal observed concentration after single-dose administration under fed condition.

    Measured in ng/mL

    Measured: From Day 44 to end of study (Day 86)

  11. Time to reach the maximal observed concentration after single-dose administration under fed condition.

    Measured in hours

    Measured: From Day 44 to end of study (Day 86)

  12. Terminal half-life after single-dose administration under fed condition.

    Measured in hours

    Measured: From Day 44 to end of study (Day 86)

  13. Incidence of ZT006 anti-drug antibody after single-dose administration under fasted condition.

    Measured in %

    Measured: From baseline to Day 43

  14. Incidence of ZT006 anti-drug antibody during and after multiple-dose administration.

    Measured in %

    Measured: From baseline to end of study (Day 77)

Timeline

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

  1. First posted29 Dec 2025
  2. Study start28 Nov 2024
  3. Primary completion14 Jun 2025
  4. Study completion24 Jun 2025

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07307638
Sponsor's protocol ID
BJQL-ZT006-1001
Status last verified
Dec 2025
First submitted
15 Dec 2025
Last updated
29 Dec 2025
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 1 study testing ZT006 in people with Overweight,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 4 inclusion and 11 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 29 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 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?

Rate of treatment-emergent adverse events after single dose administration under fasted condition. (time frame: From baseline to Day 43). 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?
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 29 Dec 2025.

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