DelfaGLP-1 Atlas

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CompletedPhase 2

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

A Randomized, Double-blind, Placebo-controlled Phase 2 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

314

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoint

•Percentage relative 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 IDNCT06226090
Org study IDSYSA1803-017

Timeline

Milestones

Study first posted2024-01-26actual
Study start2024-02-21actual
Primary completion2024-09-26actual
Study completion2024-10-24actual
Last update posted2025-05-14actual

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.

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 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\&gt;5.6mmol/L, 6) eGFR<60ml/min/1.73m^2 , 7) positive of HBsAg, HCV-antibody, HIV-antibody or anti-TP antibody, 8) WBC\&lt; 3×10^9/L, or Hb \&lt;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\&#39;s opinion.

Endpoints (18)

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

Cardiometabolic biomarkers
6
Weight & body composition
5
Other (unclassified)
4
Safety / tolerability / PK
2
Renal / kidney
1

Weight & body composition

5 endpoints
Primary/protocol endpoint

Percentage 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

Proportion of participants with weight loss of ≥ 5% at week 24

Time frame:From baseline to week 24

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants with weight loss of ≥ 10% at week 24

Time frame:From baseline to week 24

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline to week 24 in waist circumference

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Relative change from baseline in body weight at week 24

Time frame:From baseline to week 24

percent change from baseline, improvement

Renal / kidney

1 endpoint
Other/protocol endpoint

Change from baseline to week 24 in serum creatinine

Time frame:From baseline to week 24

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

Change from baseline to week 24 in systolic blood pressure

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to week 24 in diastolic blood pressure

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Title: Change from baseline to week 24 in serum total cholesterol

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Title: Change from baseline to week 24 in serum triglyceride

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Title: Change from baseline to week 24 in serum low density lipoprotein cholesterol

Time frame:From baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Title: Change from baseline to week 24 in serum high density lipoprotein cholesterol

Time frame:From baseline to week 24

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Other/protocol endpoint

Number of TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events)

Time frame:From baseline to week 27

event count, event

Other/protocol endpoint

Plasma concentration of TG103

Time frame:From baseline to week 27

concentration, descriptive

Other (unclassified)

4 endpoints
Other/protocol endpoint/low confidence

Change from baseline to week 24 in serum calcitonin

Time frame:From baseline to week 24

change from baseline, improvement

Other/protocol endpoint/low confidence

Change from baseline to week 24 in serum alanine transaminase

Time frame:From baseline to week 24

change from baseline, improvement

Other/protocol endpoint/low confidence

Change from baseline to week 24 in serum HCG (Human Chorionic Gonadotophin)

Time frame:From baseline to week 24

change from baseline, improvement

Other/protocol endpoint/low confidence

Number of patients with positive TG103 antibody

Time frame:From baseline to week 27

event count, event

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.