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This study is a randomized, double-blind, placebo-controlled trial aimed at exploring the effects of LAE102 injection in combination with Tirzepatide on body composition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Receive LAE102, once a week, by subcutaneous injection. |
|
| Placebo group | Placebo Comparator | Receive the LAE102 placebo, once a week, by subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAE102 +Tirzepatide | Drug | Receive LAE102, once a week, by subcutaneous injection.The dosage of Tirzepatide starts at lower dose, administered subcutaneously once a week, and is gradually increased every 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change in lean body mass | At 24 weeks of treatment, the lean body mass measured by dual-energy X-ray absorptiometry (DXA) compared to the baseline percentage change | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness endpoint | The change in weight at 24 weeks compared to the baseline and the corresponding percentage | 24 weeks |
| Effectiveness endpoint | Change in lean body mass from baseline at 24 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
A clear diagnosis of type 1, type 2 diabetes or other types of diabetes (excluding gestational diabetes);
Screening criteria: Glycated hemoglobin ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L.
Obesity related:
Diagnosed with secondary obesity;
Previously underwent surgical or endoscopic weight loss metabolic surgery (except for local liposuction within 1 year before screening) or gastric balloon implantation, or planned to undergo any weight loss surgery or receive other weight loss treatments during the study;
Uncontrolled thyroid disease, or screening criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoying li Professor | Contact | +862164041990 | li.xiaoying@zs-hospital.sh.cn |
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A total of 60 eligible obese participants meeting the inclusion criteria will be included in the study. They will be randomly assigned in a 1:1 ratio to the LAE102 group and the placebo group. The injections will be given subcutaneously once a week, and stratified randomization will be conducted based on gender. At the same time, all participants will receive open-label treatment with Tirzepatide(initiated with starting from lower dose once a week, subcutaneously, and titrated to higher dose levels every 4 weeks.
LAE102 and its placebo will be combined with Tirzepatide for 24 weeks of treatment.
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| LAE102 placebo,+Tirzepatide | Drug | Receive the LAE102 placebo, once a week, by subcutaneous injection. The dosage of Tirzepatide starts at lower dose, administered subcutaneously once a week, and is gradually increased to a higher dose level every 4 weeks. |
|
| 24 weeks |
| Effectiveness endpoint | Change and percentage of fat mass at 24 weeks of treatment | 24 weeks |
| Effectiveness endpoint | Changes and percentage of lean body mass in limbs at 24 weeks of treatment | 24 weeks |
| Safety endpoint | Numbers of adverse events during treatment (TEAE) | 24 weeks |