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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity Adult Onset
• Intervention / Treatment: Drug: LAE102 +Tirzepatide; Drug: LAE102 placebo,+Tirzepatide

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoying li Professor; Phone Number: +862164041990; Email: li.xiaoying@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Receive LAE102, once a week, by subcutaneous injection.	Drug: LAE102 +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.
Placebo Comparator: Placebo group; Receive the LAE102 placebo, once a week, by subcutaneous injection.	Drug: LAE102 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Investigator-initiated trial; LAE102 injection; Obesity Adult Onset
• Other Study ID Numbers: ZSJZ2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No