Efficacy and Safety of SYH2069 Injection in Obese Participants Without Diabetes.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCSPC Ouyi Pharmaceutical Co., Ltd.

About this trial

To evaluate the efficacy and safety of SYH2069 injection compared with placebo in obese Non-diabetic Participants after 28 weeks of treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Male or female participants, 18-65 years of age at the time of signing informed consent;

2.At screening visit, 28.0 kg/m²≤BMI≤ 40.0 kg/m²;

3.Maintained consistent diet and exercise habits with stable body weight within the 12 weeks prior to screening (self-reported weight variation <5%).;

4.Able to understand and comply with trial procedures, voluntarily participate in the trial, and provide written informed consent (ICF).

Disqualifiers

1. Participants with a history of diabetes mellitus or hypoglycemic episodes;

2. Participants with obesity caused by known single-gene mutations, other medical conditions, or medications, or weight gain not resulting from increased adipose tissue mass;

3. Use of any medications or products that alter body weight and interfere with weight assessment within 3 months prior to screening;

4. Prior bariatric surgery or weight-loss interventions, or plan to receive any bariatric surgery or weight-loss intervention during the trial.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SYH2069 Injection

    Drug

    0.6ml , 1.2ml , administered subcutaneously (SC),Administer the drug according to the clinical trial protocol

  • SYH2069 Injection Placebo

    Drug

    0.6ml , 1.2ml , SC,Administer the drug according to the clinical trial protocol

Treatment groups

360 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Treatment group AActive comparator 1 intervention
Group B: Treatment group BExperimental treatment 1 intervention
Group C: Treatment group CExperimental treatment 1 intervention
Group D: Treatment group DExperimental treatment 1 intervention
Group E: Treatment group EExperimental treatment 1 intervention
Group F: Treatment group FExperimental treatment 1 intervention
Group G: Treatment group GExperimental treatment 1 intervention
Group H: Treatment group HExperimental treatment 1 intervention
Group I: Treatment group IPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Relative percentage change in body weight from baseline at of treatment at 28 weeks of treatment

Time frame
28 weeks

Secondary outcomes

1

Proportion of subjects with a weight loss of ≥5% , 10%, 15% from baseline at 28 weeks of treatment

Time frame
Baseline through Week 28
2

Change from baseline in body Weight

Time frame
Week 2, 4, 8, 12, 16, 20, 24 and 28
3

Changes from baseline in waist circumference

Time frame
Baseline through Week 28
4

Changes from baseline in hip circumference

Time frame
Baseline through Week 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: