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ObesityPhase 2NCT06226090

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

A Phase 2 study testing TG103 7.5 mg, TG103 15 mg and TG103 22.5 mg in people with Obesity and Overweight, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized, double-blind, placebo-controlled, parallel phase 2 study to evaluate efficacy, safety, pharmacokinetic characteristics and immunogenicity of TG103 injection for weight management in non-diabetic patients with overweight in the presence of comorbidities or obesity, in addition to lifestyle… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity, Overweight
What is being tested?
TG103 7.5 mg, TG103 15 mg and TG103 22.5 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
314 participants
Where
1 siteChina
Study dates
21 Feb 2024to 24 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Clinical Trials Information Group

    Shijiazhuang, Hebei, 050011

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity

This study is a randomized, double-blind, placebo-controlled, parallel phase 2 study to evaluate efficacy, safety, pharmacokinetic characteristics and immunogenicity of TG103 injection for weight management in non-diabetic patients with overweight in the presence of comorbidities or obesity, in addition to lifestyle intervention.

Conditions
Obesity, Overweight
Being tested
TG103 7.5 mg, Placebo 7.5 mg, TG103 15 mg, Placebo 15 mg, TG103 22.5 mg
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TG103 7.5 mgDrug

    Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Dose is 7.5mg once a week.

  • Placebo 7.5 mgDrug

    Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Dose is 7.5mg once a week.

  • TG103 15 mgDrug

    Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg.

  • Placebo 15 mgDrug

    Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg.

  • TG103 22.5 mgDrug

    Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.

  • Placebo 22.5 mgDrug

    Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.

Study groups in NCT06226090
Study groupRoleWhat they receive
TG103 7.5 mgExperimentalNot described
Receives: Drug: TG103 7.5 mg
Placebo 7.5 mgPlacebo comparatorNot described
Receives: Drug: Placebo 7.5 mg
TG103 15 mgExperimentalNot described
Receives: Drug: TG103 15 mg
Placebo 15 mgPlacebo comparatorNot described
Receives: Drug: Placebo 15 mg
TG103 22.5 mgExperimentalNot described
Receives: Drug: TG103 22.5 mg
Placebo 22.5 mgPlacebo comparatorNot described
Receives: Drug: Placebo 22.5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage relative change from baseline in body weight at week 24

    Measured: From baseline to week 24

Secondary outcomes (10)

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

    Measured: From baseline to week 24

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

    Measured: From baseline to week 24

  3. Change from baseline to week 24 in waist circumference

    Measured: From baseline to week 24

  4. Relative change from baseline in body weight at week 24

    Measured: From baseline to week 24

  5. Change from baseline to week 24 in systolic blood pressure

    Measured: From baseline to week 24

  6. Change from baseline to week 24 in diastolic blood pressure

    Measured: From baseline to week 24

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

    Measured: From baseline to week 24

  8. Title: Change from baseline to week 24 in serum triglyceride

    Measured: From baseline to week 24

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

    Measured: From baseline to week 24

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

    Measured: From baseline to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study start21 Feb 2024
  3. Primary completion26 Sep 2024
  4. Study completion24 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06226090
Sponsor's protocol ID
SYSA1803-017
Status last verified
May 2025
First submitted
11 Jan 2024
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TG103 7.5 mg, TG103 15 mg and TG103 22.5 mg in people with Obesity and Overweight, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage relative change from baseline in body weight at week 24 (time frame: From baseline to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06226090.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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