ClinicalTrials.gg
Active, not recruitingNCT07230132Updated Jun 12, 2026

Efficacy and Safety of ZT006 in Overweight and Obese Participants

A Phase 2 interventional study of ZT006 and Placebo of ZT006 in Overweight , Obesity, sponsored by Beijing QL Biopharmaceutical Co.,Ltd. Active, not recruiting at 12 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Beijing QL Biopharmaceutical Co.,Ltd · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies in Obesity by Beijing QL Biopharmaceutical Co.,Ltd — 2 open to participants now, 7 under way, 1 of them phase 3. Obesity · Beijing QL Biopharmaceutical Co.,Ltd.

Enrollment
4th of 10
184 · median 77
Started
2025
the only one that year
Phase 2
3 of 10
1 open now
Registered
3rd of 10
by date

Among the 10 studies in Obesity by Beijing QL Biopharmaceutical Co.,Ltd, this one is the 4th largest by enrollment, is the only one that started in 2025, is one of 3 in phase 2, and was the 3rd registered.

Obesity

11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.

Browse Obesity studies →

Open to participants now

2 of the 10 studies in Obesity by Beijing QL Biopharmaceutical Co.,Ltd are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Obesity by Beijing QL Biopharmaceutical Co.,Ltd, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Overweight , Obesity

Browse trials for

04

In context

Obesity Reclassified

11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.

This study's enrollment of 184 is above the median of 67 across 9,016 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Beijing QL Biopharmaceutical Co.,Ltd is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

MAIN STUDY:

Inclusion Criteria:

  • Male or female, age between 18 - 65 years (both inclusive) at the time of signing of the .
  • (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
  • ≥ 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

06

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
184 participants (actual)

Study arms

  • Experimental
    ZT006 tablet low target dose

    administered per os, daily

    Drug: ZT006

  • Experimental
    ZT006 tablet medium target dose

    administered per os, daily

    Drug: ZT006

  • Experimental
    ZT006 tablet high target dose

    administered per os, daily

    Drug: ZT006

  • Placebo comparator
    placebo of ZT006

    administered per os, daily

    Drug: Placebo of ZT006

  • Experimental
    ZT006 tablet weekly dose 1

    administered per os, weekly

    Drug: ZT006

  • Experimental
    ZT006 tablet weekly dose 2

    administered per os, weekly

    Drug: ZT006

Interventions

  • DrugZT006

    Participants will receive a daily dose of ZT006

  • DrugPlacebo of ZT006

    Participants will receive a daily dose of placebo of ZT006

  • DrugZT006

    Participants will receive a weekly dose of ZT006

  • DrugZT006

    Participants will receive a weekly dose of ZT006

  • DrugZT006

    Participants will receive a weekly dose of ZT006

  • DrugZT006

    Participants will receive a weekly dose of ZT006

07

What researchers measure

Primary outcomes

  1. Change in body weight relative to baseline

    Percentage-point

    Time frame: 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 %

    Time frame: From week 28 to week 45

  3. Rate of serious adverse events in the extension period

    Summarized from adverse event reporting in %

    Time frame: From week 28 to week 45

Secondary outcomes

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

    Proportion of participants in %

    Time frame: 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 %

    Time frame: 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 %

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

  4. Change in body weight

    Measured in kg

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

  5. Change in waist circumference

    Measured in cm

    Time frame: 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 )

    Time frame: 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 %

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

  8. Rate of serious adverse events

    Summarized from adverse event reporting in %

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

  9. Proportion of participants with positive anti-ZT006 antibody

    Summarized in %

    Time frame: 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

    Time frame: From week 28 to week 40

  11. Change in body weight

    Measured in kg

    Time frame: From week 28 to week 40

08

Study locations

12 sites
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.

Of 176 industry-sponsored phase 2 interventional studies under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 18. This study's planned 12 months is close to that.

Counting every sponsor, half of 307 studies reached it within 16 months; a quarter within 10 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2025
First posted
Nov 17, 2025
StartActual
Dec 12, 2025
Primary completionEst.
Dec 12, 2026
CompletionEst.
Mar 31, 2027
Last update
Jun 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07230132
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Dec 12, 2025
Primary completion
Dec 12, 2026 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Jun 12, 2026

Study contacts

Linong Ji, MD
principal investigator · Peking University People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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