DelfaGLP-1 Atlas

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UnknownPhase 2

A Study of TG103 Injection in Overweight or Obesity

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study of TG103 Injection in the Management of Overweight or Obesity

Asset

TG103

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

195

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoint

•Body weight

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 IDNCT05299697
Org study IDSYSA1803-007

Timeline

Milestones

Study first posted2022-03-29actual
Study start2022-05-20estimated
Last update posted2022-05-23actual
Primary completion2023-06-30estimated
Study completion2023-09-30estimated

Assets

Investigational agents

TG103

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female, 18 years ≤ age ≤ 75 years.
•Body Mass Index (BMI) ≥ 28 kg/m^2, or 24 kg/m^2 < BMI ≤ 28 kg/m^2 with at least one of obesity-related complications.
•Regular diet and exercise and stable body weight (i.e. <5 kg self-reported change) within 12 weeks before screening as well as body weight ≥ 60 kg at screening.
•Weight loss less than 5% or weight increase after simple diet and exercise efforts for at least 3 months.
•Be able to understand the trial and complete the procedures, and be voluntary to participate in this study and sign the informed consent.

Exclusion criteria

•Screening HbA1c ≥ 6.5%, or screening FPG ≥ 7.0mmol/L or<2.8mmol/L, or history of diabetes mellitus or hypoglycemia.
•Overweight or obesity due to single gene mutation, disease or drug, or weight increase due to non-fat mass increase.
•Treatment with any medication or product which in the investigator's opinion will cause change in weight to influence trial evaluations within 12 weeks before screening or during this study.
•Subjects who underwent bariatric surgery within 12 months before screening, or are not yet recovered from any surgery or injury at screening.
•Subjects who participated in any clinical trial and received the treatment within 12 weeks before screening, or who participated in the clinical trial and received treatment with TG103 injection.
•History of allergy or suspected allergy to GLP-1 receptor agonists or antibody agents, or other severe allergy history based on which the subjects may be allergic to the study drugs in investigator's opinion.
•Personal history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2), or screening calcitonin ≥ 50 ng/L.
•Previous history or screening ultrasound includes one of the following: chronic pancreatitis, acute pancreatitis, gallstone with at least one of less than 5mm, choledocholithiasis, except that there was no cholelithiasis after treatment or cholecystectomy.
•No recovery from gastrointestinal disease or symptom at screening, or previous withdrawl of GLP-1 receptor agonist, GLP-1/GIP receptor agonist, GLP-1/GCG receptor agonist or metformin by gastrointestinal adverse drug reaction, or previous history of gastrointestinal surgery that influences the gastrointestinal motility in the investigators' opinions.
•Acute infection at screening.
•History of easily relapsed skin disease (e.g. urticaria), or present skin injury in any administration site at screening.
•History of acute coronary syndrome, stroke, severe asthma, epilepsy, systemic lupus erythematosus, hemolytic anemia, cirrhosis and the other severe disease, or history of malignant tumor.
•One of the followings at screening: systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, or NYHA ≥ grade III, or QTc interval prolongation (i.e. QTcF>450ms in males or >470ms in females) or severe arrhythmia (e.g. atrioventricular block equal to or more than II degree, ventricular tachycardia).
•History of abnormal thyroid function with requirement of medication treatment at screening, or TSH beyond the normal reference range at screening.
•One of the followings at screening: 1) ALT or AST>3 × UNL (upper normal limit), or total bilirubin>1.5 × UNL, 2) blood amylase or lipase>1.5 × UNL, 3) TG>5.6mmol/L, 4) eGFR<60ml/min/1.73m^2 (calculated by CKD-EPI formula), 5) HBsAg, HCV-antibody, HIV-antibody or anti-TP antibody positive, 6) WBC< 3×10^9/L, or Hb <100g/L, 7) INR>1.2.
•History of drug abuse, drug dependence or alcoholism.
•History of moderate to severe depression, or screening Patient Health Questionaire-9 (PHQ-9) score ≥ 15.
•The fertile female who is pregnant, breast-feeding or with blood HCG positive at screening, or the fertile male or female cannot use an effective contraceptive method during the trial and for 3 months after the end of treatment.
•Other situations that are not suitable for the study in the investigator's opinion.

Endpoints (21)

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

Weight & body composition
7
Cardiometabolic biomarkers
5
Glycemic / diabetes
4
Safety / tolerability / PK
3
Patient-reported / QoL
1
Other (unclassified)
1

Weight & body composition

7 endpoints
Primary/protocol endpoint

Relative change from baseline in body weight at week 24

Time frame:From baseline to week 24

percent change from baseline, improvement

Secondary/protocol endpoint

Relative change from baseline in body weight (%) at week 12 and week 27

Time frame:From baseline to week 27

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects with weight loss of ≥ 5% and ≥ 10% of baseline body weight at week 12 and week 24

Time frame:From baseline to week 24

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline to 12 weeks, 24 weeks and 27 weeks in body weight

Time frame:From baseline to week 27

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to 12 weeks, 24 weeks and 27 weeks in BMI

Time frame:From baseline to week 27

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to 12 weeks, 24 weeks and 27 weeks in waist to hip circumference ratio

Time frame:From baseline to week 27

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to 12 weeks, 24 weeks and 27 weeks in waist circumference

Time frame:From baseline to week 27

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

Change from baseline to 12 weeks and 24 weeks in HbA1c

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to 12 weeks and 24 weeks in FPG (fasting plasma glucose)

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to 12 weeks and 24 weeks in FINS (fasting insulin)

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to 12 weeks and 24 weeks in HOMA-IR

Time frame:From baseline to week 24

change from baseline, improvement

Cardiometabolic biomarkers

5 endpoints
Secondary/protocol endpoint

Change from baseline to 12 weeks and 24 weeks in TC（total cholesterol）

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to 12 weeks and 24 weeks in TG（triglyceride）

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to 12 weeks and 24 weeks in LDLC（low density lipoprotein cholesterol）

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to 12 weeks and 24 weeks in HDLC（high density lipoprotein cholesterol）

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to 12 weeks and 24 weeks in systolic blood pressure and diastolic blood pressure

Time frame:From baseline to week 24

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change from baseline to 12 weeks and 24 weeks in scores of the patient health questionnaire (PHQ-9)

Time frame:From baseline to week 24

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Number of TEAEs and SAEs from baseline to week 27

Time frame:From baseline to week 27

event count, event

Other/protocol endpoint

Ctrough (the trough plasma concentration of TG103)

Time frame:From baseline to week 24

concentration, descriptive

Other/protocol endpoint

Number of participants with Anti-TG103 antibodies positive

Time frame:From baseline to week 27

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from baseline to 12 weeks and 24 weeks in fasting C peptide

Time frame:From baseline to week 24

change from baseline, improvement

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.