GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study of TG103 in Chinese Healthy Adult Subjects

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase Ia Study in Chinese Healthy Adult Subjects to Investigate the Safety, Tolerability and Pharmacokinetic of TG103

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Asset

TG103

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18.9-27.9•HbA1c ≤5.7%

Primary endpoint

•One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator

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 IDNCT03990090

Org study IDTG103/201901

Timeline

Milestones

Study first posted2019-06-18actual

Study start2019-07-29actual

Primary completion2020-11-11actual

Study completion2020-11-11actual

Last update posted2020-11-24actual

Assets

Investigational agents

TG103

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Age ≥ 18 years old and ≤ 65 years old, male or female;

•Medical history, physical examination, vital signs, 12-lead ECG and laboratory examination, imaging examination (thyroid color Doppler ultrasound, abdominal color Doppler ultrasound, chest X-ray) in the normal range, or not in the normal range but the researchers consider they have no clinical significance;

•The weighing no less than 50 kg in male subjects, and no less than 45 kg in female subjects , body mass index (BMI) between 18.9 and 27.9 kg/m2 (including boundary values)

•Fasting blood glucose is between 3.9-6.1 mmol/L (excluding the boundary value), and HbA1c is <5.7%;

•Subjects must use reliable methods of contraception throughout the study period and avoid pregnancy in women or pregnancy in male subjects' partners at least 3 months after dosing;

•The subject is fully aware of the test content and possible adverse reactions, and has the ability to communicate properly with the researcher while complying with the research requirements;

•Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

•Have a history of severe drug or food allergies, or who may be allergic to the test drug by the investigator;

•Have serious history of pancreas, liver, kidney, gastrointestinal tract, cardiovascular, respiratory, hematological, central nervous system disease, etc.，or other important disease that have risks may endanger the safety of the subject or affect the absorption, metabolism, excretion, etc. of the study drug，or the investigator believes that the subject is not suitable for inclusion.

•Have undergone major surgery within 3 months prior to the trial, or have experienced severe infection within 4 weeks prior to the trial;

•Have diabetes, thyroid dysfunction or other endocrine diseases that may affect blood sugar metabolism;

•Individual or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia, or other genetic diseases that are susceptible to medullary medullary cancer;

•Those with history of malignant tumors and mental illness, depression, anxiety, and epilepsy disease.

•Drugs and drug abusers in the past three years;

•Vaccination within 28 days prior to the trial or planned to be vaccinated within 1 week of receiving the study drug;

•Has one or more positive tests in Hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti- Treponema pallidum-specific antibody;

•Lost more than 400 ml of blood due to blood donation or other reasons within 3 months before the test;

•Apply a glucagon-like peptide-1(GLP-1 )analogue, a glucagon-like peptide-1(GLP-1 )receptor agonist, or any other incretin mimetic 1 month prior to the planned study drug, or other drugs that the investigator believes may affect the trial;

•Those who took prescription or similar over-the-counter medications within 1 month prior to the trial to promote weight loss (eg, orlistat, sibutramine, rimonabant, phenylpropanolamine or chlorpheniramine) ;

•Alcohol intake is more than 21 units of alcohol per week (male) / 14 units of alcohol per week(female) (1 unit ≈ 360mL beer, or 45mL spirits with 40% alcohol content, or 150mL wine) 3 months prior to the screening.

•Regular consumption of caffeine more than 600 mg per day in the past 3 months (1 cup of coffee contains about 100 mg of caffeine, 1 cup of tea contains about 30 mg of caffeine, and 1 can of Coke contains about 20 mg of caffeine);

•Those who have taken caffeinated products or drugs within 48 hours prior to the study;

•Taken more than 5 cigarettes per day in the past 3 months;

•The investigator considers that the subject's diet has a big difference in the ratio to normal protein, carbohydrate, and fat intake (eg, vegetarian)person;

•There are symptoms such as dermatitis or skin abnormalities at the site of administration;

•Participated in other drug studies within 3 months prior to the planned study drug or the time of the last test drug was less than 3 months prior to screening for the trial; or attempted to participate in other drug trials during the study;

•Pregnancy, lactation or blood human chorionic gonadotropin(HCG) positive in pregnancy test;

•Drug abuse screening, alcohol breath test positive;

•Failure to ensure full participation in the trial;

•Others who have been judged by the investigator that inappropriate to participate in the study.

Endpoints (10)

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

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Fasting blood glucose

Time frame:1,2,3,4,5,7days

descriptive

Secondary/protocol endpoint

2-hour postprandial blood glucose

Time frame:1,2,3,4,5,7days

descriptive

Secondary/protocol endpoint

fasting insulin

Time frame:-1,3days

descriptive

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline through Day 28

event count, event

Secondary/protocol endpoint

Area under the plasma concentration versus time curve (AUC)

Time frame:0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648h

concentration, descriptive

Secondary/protocol endpoint

Peak Plasma Concentration (Cmax)

Time frame:0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648h

concentration, descriptive

Secondary/protocol endpoint

Time to maximum plasma concentration（Tmax）

Time frame:0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648hours

time to event, event

Secondary/protocol endpoint

Half time (t1/2)

Time frame:0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648hours

concentration, descriptive

Secondary/protocol endpoint

Apparent clearance (CL/F)

Time frame:0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648hours

concentration, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

fasting glucagon

Time frame:-1,3days

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Safety, pharmacokinetics, and pharmacodynamics of TG103, a novel long-acting GLP-1/Fc fusion protein after a single ascending dose in Chinese healthy subjects.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences2023 Jun 1PMID37062422doi:10.1016/j.ejps.2023.106448via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.