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NCT Number: NCT07671391

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

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Key information

Conditions

Obesity Adult Onset

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%;

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Effectiveness endpoint

    Time frame: 24 weeks

    The change in weight at 24 weeks compared to the baseline and the corresponding percentage

  2. Effectiveness endpoint

    Time frame: 24 weeks

    Change in lean body mass from baseline at 24 weeks of treatment

  3. Effectiveness endpoint

    Time frame: 24 weeks

    Change and percentage of fat mass at 24 weeks of treatment

  4. Effectiveness endpoint

    Time frame: 24 weeks

    Changes and percentage of lean body mass in limbs at 24 weeks of treatment

  5. Safety endpoint

    Time frame: 24 weeks

    Numbers of adverse events during treatment (TEAE)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoying li Professor

CONTACT

[email protected]

+862164041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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