DelfaGLP-1 Atlas

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CompletedPhase 3

A Study of TG103 Injection in Non-diabetic Overweight or Obesity

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity

Asset

TG103

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

675

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoints

•Weight loss of ≥ 5%•Relative percentage change from baseline in 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 IDNCT05997576
Org study IDSYSA1803-013

Timeline

Milestones

Study first posted2023-08-18actual
Study start2023-11-22actual
Primary completion2025-02-17actual
Study completion2025-03-03actual
Last update posted2025-08-11actual

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., self-reported body weight change < 5%) within 12 weeks before screening as well as body weight ≥ 60 kg at screening.
•Weight loss less than 5% or no weight loss after diet and exercise intervention for at least 12 weeks.
•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

•History of type 2 diabetes, type 1 diabetes or hypoglycemia.
•Overweight or obesity due to disease or drug; or weight increase due to non-fat mass increase; or monogenic obesity.
•Medications or products which are judged by investigators to cause change in weight and influence trial evaluations have been used within 12 weeks before screening or will be used during study.
•Weight loss less than 5% by monotherapy or combination with GLP-1 receptor agonists for at least 12 weeks before screening.
•Bariatric surgery within 12 months before screening; or no full recovery from any surgery or injury at screening; or gastrointestinal motility dysfunction due to gastrointestinal surgery.
•Participation in any clinical trial to receive treatment within 12 weeks before screening, or participation in clinical trial to receive TG103 before screening.
•History of allergy or suspected allergy to GLP-1 receptor agonists or antibody agents, or suspected allergy to TG103 judged by investigator due to other severe allergy history.
•Personal history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).
•History or screening ultrasound reports of chronic pancreatitis, acute pancreatitis, etc.
•History of severe gastrointestinal disease; or gastrointestinal symptom at screening; or discontinuation of GLP-1 receptor agonist, GLP-1/GIP receptor agonist, GLP-1/GCG receptor agonist or metformin due to gastrointestinal adverse reaction.
•Severe infection at screening.
•Skin disorder that influences safety evaluation at screening.
•History of severe disease or malignant tumor.
•Systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg, NYHA Grade Ⅲ-Ⅳ, QTc interval prolongation or severe arrhythmia at screening.
•History of abnormal thyroid function with requirement of medication treatment at screening, or screening TSH beyond the normal reference range.
•One of the followings at screening: 1) HbA1c ≥ 6.5%, or screening FPG ≥ 7.0mmol/L or<2.8mmol/L; 2) calcitonin ≥ 50 ng/L; 3) ALT or AST>3 × UNL (upper normal limit), or total bilirubin>1.5 × UNL; 4) blood amylase or lipase>1.5 × UNL, 5) TG>5.6mmol/L, 6) eGFR<60ml/min/1.73m2 , 7) positive of HBsAg, HCV-antibody, HIV-antibody or anti-TP antibody, 8) WBC< 3×10^9/L, or Hb <100g/L, 9) 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 participants and their partner cannot use an effective contraceptive method during the trial and within 3 months after the end of treatment.
•Other situations unsuitable for this study in the investigator's opinion.

Endpoints (20)

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
6
Glycemic / diabetes
3
Other (unclassified)
2
Patient-reported / QoL
1
Safety / tolerability / PK
1

Weight & body composition

7 endpoints
Primary/protocol endpoint

Proportion of participants with weight loss of ≥ 5% at week 40

Time frame:From baseline to week 40

threshold achievement, improvement

Primary/protocol endpoint

Relative percentage change from baseline in body weight at week 40

Time frame:From baseline to week 40

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of participants with weight loss of ≥ 5% at week 52

Time frame:From baseline to week 52

threshold achievement, improvement

Secondary/protocol endpoint

Relative percentage change from baseline in body weight at week 52

Time frame:From baseline to week 52

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of participants with weight loss of ≥ 10%

Time frame:From baseline to week 40, 52

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in body weight (kg)

Time frame:From baseline to week 40, 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference (cm)

Time frame:From baseline to week 40, 52

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change from baseline in HbA1c (%)

Time frame:From baseline to week 40, 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fasting plasma glucose (mmol/L)

Time frame:From baseline to week 40, 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fasting insulin (mU/L)

Time frame:From baseline to week 40, 52

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

Change from baseline in total cholesterol (mmol/L)

Time frame:From baseline to week 40, 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in triglyceride (mmol/L)

Time frame:From baseline to week 40, 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in low density lipoprotein cholesterol (mmol/L)

Time frame:From baseline to week 40, 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in high density lipoprotein cholesterol (mmol/L)

Time frame:From baseline to week 40, 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in systolic blood pressure (mmHg)

Time frame:From baseline to week 40, 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in diastolic blood pressure (mmHg)

Time frame:From baseline to week 40, 52

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Other/protocol endpoint

Proportion of participants categorized by patient health questionnaire-9 (PHQ-9) score

Time frame:From baseline to week 52

threshold achievement, improvement

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint

Number of TEAEs and SAEs assessed by CTCAE V5.0

Time frame:From baseline to week 55

event count, event

Other (unclassified)

2 endpoints
Other/protocol endpoint/low confidence

Concentration of TG103 (Ctrough)

Time frame:From baseline to week 55

concentration, descriptive

Other/protocol endpoint/low confidence

Proportion of anti-TG103-antibody-positive participants

Time frame:From baseline to week 55

threshold achievement, 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.