Obesity Adult OnsetPhase 2NCT07671391
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body in Obese Participants
A Phase 2 study testing LAE102 +Tirzepatide in people with Obesity Adult Onset, run by Shanghai Zhongshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity Adult Onset
- What is being tested?
- LAE102 +Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Voluntarily participate in the study and sign the Informed Consent Form (ICF);
- Male or female participants aged between 18 and 75 years (inclusive) at the time of signing the ICF;
- BMI ranging from 28.0 to 40.0 kg/m2 during the screening;
- 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%;
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body Composition in Obese Participants
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.
- Conditions
- Obesity Adult Onset
- Being tested
- LAE102 +Tirzepatide, LAE102 placebo,+Tirzepatide
- Keywords
- LAE102 injection, Obesity Adult Onset, Investigator-initiated trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAE102 +TirzepatideDrug
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.
LAE102 placebo,+TirzepatideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Receive LAE102, once a week, by subcutaneous injection. Receives: Drug: LAE102 +Tirzepatide |
| Placebo group | Placebo comparator | Receive the LAE102 placebo, once a week, by subcutaneous injection. Receives: Drug: LAE102 placebo,+Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (5)
Effectiveness endpoint
The change in weight at 24 weeks compared to the baseline and the corresponding percentage
Measured: 24 weeks
Effectiveness endpoint
Change in lean body mass from baseline at 24 weeks of treatment
Measured: 24 weeks
Effectiveness endpoint
Change and percentage of fat mass at 24 weeks of treatment
Measured: 24 weeks
Effectiveness endpoint
Changes and percentage of lean body mass in limbs at 24 weeks of treatment
Measured: 24 weeks
Safety endpoint
Numbers of adverse events during treatment (TEAE)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Adult OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671391
- Sponsor's protocol ID
- ZSJZ2026
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body Composition in Obese Participants
- ClinicalTrials.gov ID
- NCT07671391
- Acronym / sponsor ID
- ZSJZ2026
- Conditions
- Obesity Adult Onset
- Keywords
- LAE102 injection, Obesity Adult Onset, Investigator-initiated trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: LAE102 +TirzepatideReceive LAE102, once a week, by subcutaneous injection. |
| Placebo group | Placebo comparator | Drug: LAE102 placebo,+TirzepatideReceive the LAE102 placebo, once a week, by subcutaneous injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily participate in the study and sign the Informed Consent Form (ICF);
- Male or female participants aged between 18 and 75 years (inclusive) at the time of signing the ICF;
- BMI ranging from 28.0 to 40.0 kg/m2 during the screening;
- 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%;
Key exclusion criteria (6 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAE102 +TirzepatideReceive 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. | Drug | Treatment group |
| LAE102 placebo,+TirzepatideReceive 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. | Drug | Placebo group |
Primary outcome
The percentage change in lean body mass
Time frame: 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
5 secondary outcomes
Effectiveness endpoint
Time frame: 24 weeks
Effectiveness endpoint
Time frame: 24 weeks
Effectiveness endpoint
Time frame: 24 weeks
Effectiveness endpoint
Time frame: 24 weeks
Safety endpoint
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LAE102 +Tirzepatide in people with Obesity Adult Onset, run by Shanghai Zhongshan Hospital.
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 6 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: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoying li Professor (+862164041990, li.xiaoying@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change in lean body mass (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.