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

NCT ID: NCT07307638

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-28

Study Completion Date

2025-06-24

Brief Summary

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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.

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.

Detailed Description

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Conditions

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Overweight,Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ZT006 tablet, dose level 1, single dose, fasted

Group Type EXPERIMENTAL

ZT006

Intervention Type DRUG

Participants will receive a single dose of ZT006 of dose level 1 under fasted condition.

ZT006 tablet, dose level 2, single dose, fasted

Group Type EXPERIMENTAL

ZT006

Intervention Type DRUG

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

ZT006 tablet, dose level 3, single dose, fasted

Group Type EXPERIMENTAL

ZT006

Intervention Type DRUG

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

ZT006 tablet, dose level 4, single dose, fasted and fed

Group Type EXPERIMENTAL

ZT006

Intervention Type DRUG

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.

ZT006 tablet, dose level 5, single dose, fasted

Group Type EXPERIMENTAL

ZT006

Intervention Type DRUG

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

ZT006 tablet, multiple doses, cohort 1

Group Type EXPERIMENTAL

ZT006

Intervention Type DRUG

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.

ZT006 tablet, multiple doses, cohort 2

Group Type EXPERIMENTAL

ZT006

Intervention Type DRUG

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.

ZT006 tablet, multiple doses, cohort 3

Group Type EXPERIMENTAL

ZT006

Intervention Type DRUG

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.

ZT006 tablet, multiple doses, cohort 4

Group Type EXPERIMENTAL

ZT006

Intervention Type DRUG

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 ZT006, single dose, fasted

Group Type PLACEBO_COMPARATOR

Placebo of ZT006

Intervention Type DRUG

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

placebo of ZT006, single dose, fasted and fed

Group Type PLACEBO_COMPARATOR

Placebo of ZT006

Intervention Type DRUG

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 ZT006, multiple doses

Group Type PLACEBO_COMPARATOR

Placebo of ZT006

Intervention Type DRUG

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

Interventions

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ZT006

Participants will receive a single dose of ZT006 of dose level 1 under fasted condition.

Intervention Type DRUG

ZT006

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

Intervention Type DRUG

ZT006

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

Intervention Type DRUG

ZT006

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.

Intervention Type DRUG

ZT006

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

Intervention Type DRUG

ZT006

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.

Intervention Type DRUG

ZT006

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.

Intervention Type DRUG

ZT006

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.

Intervention Type DRUG

ZT006

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.

Intervention Type DRUG

Placebo of ZT006

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

Intervention Type DRUG

Placebo of ZT006

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.

Intervention Type DRUG

Placebo of ZT006

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing QL Biopharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Hu, MD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Anhui Medical University

Yijun Du, Master

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Anhui Medical University

Locations

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The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Countries

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China

Other Identifiers

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BJQL-ZT006-1001

Identifier Type: -

Identifier Source: org_study_id