A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body in Obese Participants

NCT07671391 | Not Yet Recruiting Phase 2

• 1 other identifier: ZSJZ2026
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity Adult Onset

Keywords

LAE102 injection; Obesity Adult Onset; Investigator-initiated trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Effectiveness endpoint

  24 weeks

• Effectiveness endpoint

  24 weeks

• Effectiveness endpoint

  24 weeks

• Effectiveness endpoint

  24 weeks

• Safety endpoint

  24 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Receive LAE102, once a week, by subcutaneous injection.

Drug: LAE102 +Tirzepatide

Placebo group

PLACEBO COMPARATOR

Receive the LAE102 placebo, once a week, by subcutaneous injection.

Drug: LAE102 placebo,+Tirzepatide

Interventions

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.

Treatment group

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Central Study Contacts

Xiaoying li Professor

CONTACT

+862164041990; li.xiaoying@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 26, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share