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

ConditionObesity Adult Onset
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
24 weeks

Secondary outcomes

1

Effectiveness endpoint

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

Time frame
24 weeks
2

Effectiveness endpoint

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

Time frame
24 weeks
3

Effectiveness endpoint

Change and percentage of fat mass at 24 weeks of treatment

Time frame
24 weeks
4

Effectiveness endpoint

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

Time frame
24 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: