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NCT Number: NCT07230132

Efficacy and Safety 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.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Overweight , Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Handan First Hospital, Handan, Hebei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

MAIN STUDY:

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Calcitonin ≥ 50 ng/L at screening

EXTENSION PERIOD:

Inclusion criteria

  • 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

Exclusion criteria

  • Participation in the dense PK sampling in the main study
  • BMI ≤18.5 kg/m² at week 28 visit in the main study

Treatment and study plan

ZT006

Drug

Participants will receive a daily dose of ZT006

Placebo of ZT006

Drug

Participants will receive a daily dose of placebo of ZT006

Primary outcomes

  1. Change in body weight relative to baseline

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

    Percentage-point

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

    Time frame: From week 28 to week 45

    Summarized from adverse event reporting in %

  3. Rate of serious adverse events in the extension period

    Time frame: From week 28 to week 45

    Summarized from adverse event reporting in %

Secondary outcomes

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

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

    Proportion of participants in %

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

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

    Proportion of participants in %

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

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

    Proportion of participants in %

  4. Change in body weight

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

    Measured in kg

  5. Change in waist circumference

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

    Measured in cm

  6. Change in body mass index (BMI)

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

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

  7. Rate of treatment-emergent adverse events

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

    Summarized from adverse event reporting in %

  8. Rate of serious adverse events

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

    Summarized from adverse event reporting in %

  9. Proportion of participants with positive anti-ZT006 antibody

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

    Summarized in %

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

    Time frame: From week 28 to week 40

    Percentage point

  11. Change in body weight

    Time frame: From week 28 to week 40

    Measured in kg

Sponsors and collaborators

Lead sponsor

Beijing QL Biopharmaceutical Co.,Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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