ClinicalTrials.gg
Active, not recruitingNCT07550816Updated Oct 21, 2026

Drug-drug Interaction Study of ZT002 Injection in Overweight and Obese Participants

A Phase 1 interventional study of ZT002 injection, metformin, warfarin and ZT002 injection, rosuvastatin, digoxin in Overweight,Obesity, sponsored by Beijing QL Biopharmaceutical Co.,Ltd. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.

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 1, Interventional, and Treatment

Updated Oct 21, 2026Now Active, not recruitingGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Where this study stands

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

Among 81 studies testing metformin in Obesity — 15 open to participants now, 17 under way, 3 of them phase 3. Metformin · Obesity.

Planned enrollment
42nd of 81
60 · median 62
Started
2026
with 4 others
Phase 1
9 of 81
1 open now
Primary completion
2026-12
later than 8 of 16 live
Registered
77th of 81
by date
Lead sponsor
1 of 81
Beijing QL Biopharmaceutical Co.,Ltd

Among the 81 studies testing metformin in Obesity, this one is the 42nd largest by planned enrollment, is one of 5 that started in 2026, is one of 9 in phase 1, reaches primary completion later than 8 of the 16 other live ones, and was the 77th 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

15 of the 81 studies testing metformin in Obesity are open now, in 9 countries. Recruiting first, the newest first:

10 more — sign in →

By country, each count listing its studies:

All 15 open studies →

About metformin

Metformin: first FDA approval 1995 (GLUCOPHAGE), first EMA approval 2003. What it is approved for, and how studies give it, is on its page →

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 45 Years · all sexes · healthy volunteers too.

The full table on the hub →

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

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 81 studies testing metformin in Obesity, or all of them as a file.
02

Study summary

ZT002 is an ultralong-acting glucagon-like peptide-1. This open-label, fixed sequence, two-period crossover drug-drug interaction study is designed to evaluate the impact of ZT002 on the PK of metformin, warfarin, rosuvastatin and digoxin. The study will include obese and overweight but otherwise healthy participants aged 18 - 45.

The study consists of two cohorts. Each participant can only join one of the cohorts.

Cohort 1 evaluates the impact of ZT002 on the PK of metformin at steady state and on the PK of a single dose of warfarin. Participants are screened within 2 weeks before study drug administration. In the first period, metformin is given twice daily for 3.5 days and warfarin is given as a single dose without ZT002. In the second period, metformin and warfarin are given, following the same dose and regimen as in the first period, concomitantly with ZT002, which reaches steady state by up-titration. The participants will be followed up for 6 weeks after the last dose of ZT002.

Cohort 2 evaluates the impact of ZT002 on the PK of single doses of rosuvastatin and digoxin. Participants are screened within 2 weeks before study drug administration. In the first period, rosuvastatin and digoxin are given as single doses without ZT002. In the second period, rosuvastatin and digoxin are given, following the same dose and regimen as in the first period, concomitantly with ZT002, which reaches steady state by up-titration. The participants will be followed up for 6 weeks after the last dose of ZT002.

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 planned enrollment of 60 is below 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 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Age between 18 - 45 years (both inclusive) at the time of signing of the ;
  • Male (body weight >60.0 kg) or female (body weight >55.0 kg). (BMI) 24.0 - 35.0 kg/m²(both inclusive);
  • Considered to be generally healthy based on physical examination, and the results of vital signs, 12-lead and clinical laboratory tests (hematology, urinalysis, chemistry, coagulation), as judged by the investigator.

Exclusion Criteria:

  • diseases detected within 6 months before screening (including but not limited to neurological, psychiatric, cardiovascular, endocrine, gastrointestinal, respiratory, urinary, hematological, immunological diseases), judged by the investigator as possible to influence the study result or introduce safety risk to study drug administration;
  • History of dysphagia or any gastrointestinal tract disease that affects drug absorption;
  • Known (asthma, hypersensitivity to GLP-1 receptor agonists or ), or known hypersensitivity to ZT002 injection;
  • History of inspirational pneumonia within 5 years before screening;
  • Medical history of hypoglycemia within 6 months before screening;
  • History of acute or chronic pancreatitis;
  • Cholelithiasis ≤ 1 cm, or history of cholecystitis or other symptomatic gallbladder disease, with the exception of cholecystectomy > 6 months prior to screening;
  • History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;
  • (HbA1c) ≥ 6.5% or fasting plasma glucose ≥ 7.0 mmol/L at screening;
  • ≥ 2 × (ULN), Alanine aminotransferase ≥ 2 × ULN,
  • Alkaline phosphatase total ≥ 1.5 × ULN;
  • Calcitonin above ULN at screening;
  • Thyroid stimulating hormone (TSH) \< 0.4 or >6.0 mIU/L;
  • Use of hypoglycemic drugs (e.g. insulin, insulin secretagogues, thiazolidinedione, sodium-dependent glucose transporters 2 inhibitors [SGLT2i], dipeptidyl peptidase 4 inhibitor [DPP-4i], glucagon-like peptide-1 receptor agonist [GLP-1RA], metformin, α-glucosidase inhibitor) within 3 months before screening;
  • Use of prescription drugs, over-the-counter drugs, dietary supplements, vitamins, or herbal medicines (excluding topical eye/nose drops and external use on the skin without systemic exposure risk) within 2 weeks before screening.

Exclusion criteria only applicable to Cohort 1:

  • History that increases risk of bleeding, e.g. aneurysm, aortic dissection, cerebral vascular malformation, acute gastritis, gastric or duodenal ulcer; hemorrhoid bleeding within 1 month prior to screening;
  • Hypersensitivity to metformin or warfarin;
  • (PT), international normalized ratio (INR) or activated partial thromboplastin time (APTT) above ULN and judged as clinically significant by investigator;
  • \< 100x109/L;
  • Ventricular rate \< 50 or > 100 bpm, second or third degree of atrioventricular block, left bundle branch block, complete right bundle branch block, or corrected by Fridericia's formula (QTcF) > 450 ms, or other abnormal electrocardiogram of clinical significance.

Exclusion criteria only applicable to Cohort 2:

  • History of unexplained myalgia or myasthenia, or diagnosed with rhabdomyolysis;
  • Hypersensitivity to rosuvastatin or digoxin;
  • Unexplained creatine kinase above ULN;
  • Serum potassium out of reference range;
  • Ventricular rate \< 55 or > 100 bpm, atrial fibrillation, atrioventricular block of any degree, preexcitation syndrome, left bundle branch block, complete right bundle branch block, or QT interval corrected by Fridericia's formula (QTcF) > 450 ms, or other abnormal electrocardiogram of clinical significance.
Terms in these criteria, in plain language(13)

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.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

06

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    cohort1

    ZT002 injection, metformin, warfarin

    Drug: ZT002 injection, metformin, warfarin

  • Experimental
    cohort2

    ZT002 injection, rosuvastatin, digoxin

    Drug: ZT002 injection, rosuvastatin, digoxin

Interventions

  • DrugZT002 injection, metformin, warfarin

    Drug pages: ZT002 · Metformin · Warfarin

    Drug: metformin Participants will receive metformin twice daily for 3.5 days in both periods Drug: warfarin Participants will receive a single dose of warfarin in both periods Drug: ZT002 Participants will receive multiple doses of ZT002 in the second period

  • DrugZT002 injection, rosuvastatin, digoxin

    Drug pages: ZT002 · Rosuvastatin · Digoxin

    Drug: rosuvastatin Participants will receive a single dose of rosuvastatin in both periods Drug: digoxin Participants will receive a single dose of digoxin in both periods Drug: ZT002 Participants will receive multiple doses of ZT002 in the second period

07

What researchers measure

Primary outcomes

  1. Area under the concentration-time curve of metformin within dosing interval (12 hours) at steady state

    Time frame: From Day 4 to Day 5, from Day 112 to Day 113

  2. Area under the concentration-time curve of S-warfarin from time zero to infinity after single-dose administration

    Time frame: From Day 6 to Day 13, from Day 126 to Day 133

  3. Area under the concentration-time curve of R-warfarin from time zero to infinity after single-dose administration

    Time frame: From Day 6 to Day 13, from Day 126 to Day 133

  4. Area under the concentration-time curve of rosuvastatin from time zero to infinity after single-dose administration

    Time frame: From Day 1 to Day 5, from Day 111 to Day 115

  5. Area under the concentration-time curve of digoxin from time zero to infinity after single-dose administration

    Time frame: From Day 5 to Day 12, from Day 125 to Day 132

Secondary outcomes

  1. Maximal observed concentration of metformin at steady state

    Time frame: From Day 4 to Day 5, from Day 112 to Day 113

  2. Maximal observed concentration of S-warfarin after single-dose administration

    Time frame: From Day 6 to Day 13, from Day 126 to Day 133

  3. Maximal observed concentration of R-warfarin after single-dose administration

    Time frame: From Day 6 to Day 13, from Day 126 to Day 133

  4. Maximal observed concentration of rosuvastatin after single-dose administration

    Time frame: From Day 1 to Day 5, from Day 111 to Day 115

  5. Maximal observed concentration of digoxin after single-dose administration

    Time frame: From Day 5 to Day 12, from Day 125 to Day 132

  6. Area under the INR-time curve after single-dose warfarin administration

    Time frame: From Day 6 to Day 13, from Day 126 to Day 133

  7. Maximal INR after single-dose warfarin administration

    Time frame: From Day 6 to Day 13, from Day 126 to Day 133

  8. Percentage change in body weight

    Time frame: Day 13 and Day 133 in Cohort 1, Day 12 and Day 132 in Cohort 2

  9. Proportion of participants with positive anti-drug antibody against ZT002

    Time frame: From Day 13 to Day 167 in Cohort 1, from Day 12 to Day 166 in Cohort 2

  10. Proportion of participants with treatment-emergent adverse events

    Time frame: From baseline to Day 167 in Cohort 1, from baseline to Day 166 in Cohort 2

  11. Proportion of participants with serious adverse events

    Time frame: From baseline to Day 167 in Cohort 1, from baseline to Day 166 in Cohort 2

08

Study locations

1 site
09

Timeline

1 registry update 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 May 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.

Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 6 months is below that.

Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

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

Registered
Apr 20, 2026
First posted
Apr 24, 2026
StartActual
May 27, 2026
Primary completionEst.
Dec 5, 2026
CompletionEst.
Mar 26, 2027
Last update
Oct 21, 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.
Status
Recruiting→Active, not recruiting
changed Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    Recruiting→Active, not recruiting
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07550816
Responsible party
Sponsor
First posted
Apr 24, 2026
Start date
May 27, 2026
Primary completion
Dec 5, 2026 (estimated)
Completion
Mar 26, 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

Qin Yu, Master
principal investigator · West China Second University Hospital

Oversight

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 Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: ZT002 · Metformin · Warfarin · Rosuvastatin · Digoxin

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