GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

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

Lead sponsor

Beijing QL Biopharmaceutical Co.,Ltd

Asset

ZT006

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 19-35•Healthy volunteers

Primary endpoints

•Treatment-emergent adverse events after single dose administration under fasted•Treatment-emergent adverse events during and after multiple-dose administration•Treatment-emergent adverse events after single dose administration under fed

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07307638

Org study IDBJQL-ZT006-1001

Timeline

Milestones

Study start2024-11-28actual

Primary completion2025-06-14actual

Study completion2025-06-24actual

Study first posted2025-12-29actual

Last update posted2025-12-29actual

Assets

Investigational agents

ZT006

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

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.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

11 endpoints

Primary/protocol endpoint

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

Time frame:From baseline to Day 43

ratio, event

Primary/protocol endpoint

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

Time frame:From baseline to end of study (Day 77)

ratio, event

Primary/protocol endpoint

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

Time frame:From Day 44 to end of study (Day 86)

ratio, event

Secondary/protocol endpoint

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

Time frame:From baseline to Day 43

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:From baseline to Day 43

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Day 42 to Day 77

concentration, descriptive

Secondary/protocol endpoint

Terminal half-life at steady state.

Time frame:From Day 42 to Day 77

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:From Day 44 to end of study (Day 86)

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:From Day 44 to end of study (Day 86)

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:From baseline to Day 43

event count, event

Secondary/protocol endpoint

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

Time frame:From baseline to end of study (Day 77)

event count, event