Obesity Adult Onset
Conditions
Keywords
LAE102 injection, Obesity Adult Onset, Investigator-initiated trial
Brief summary
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.
Interventions
DRUGLAE102 +Tirzepatide
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.
DRUGLAE102 placebo,+Tirzepatide
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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily participate in the study and sign the Informed Consent Form (ICF); 2. Male or female participants aged between 18 and 75 years (inclusive) at the time of signing the ICF; 3. BMI ranging from 28.0 to 40.0 kg/m2 during the screening; 4. Self-reporting at least one experience of weight loss failure after adjusting diet and exercise, and within the previous 3 months, the weight change after only dietary and exercise adjustments was less than 5%;
Exclusion criteria
1. A clear diagnosis of type 1, type 2 diabetes or other types of diabetes (excluding gestational diabetes); 2. Screening criteria: Glycated hemoglobin ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L. Obesity related: 3. Diagnosed with secondary obesity; 4. 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; 5. Uncontrolled thyroid disease, or screening criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage change in lean body mass | 24 weeks | At 24 weeks of treatment, the lean body mass measured by dual-energy X-ray absorptiometry (DXA) compared to the baseline percentage change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness endpoint | 24 weeks | The change in weight at 24 weeks compared to the baseline and the corresponding percentage |
| Safety endpoint | 24 weeks | Numbers of adverse events during treatment (TEAE) |
Contacts
CONTACTXiaoying li Professor
Outcome results
None listed