Current partner codePEPTIDESDE
NCT07671391·Phase 2·INTERVENTIONAL

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

Status

Not yet recruiting

Phase

Phase 2

Enrollment

60

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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.

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.

Timeline

From registration to results.

  1. First posted

    Jun 26, 2026

  2. Study start

    Aug 2026

  3. Primary completion

    Jul 2027

  4. Study completion

    Dec 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jun 26, 2026

Outcomes

What the study measures.

Primary outcomes

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

Effectiveness endpoint

Time frame · 24 weeks

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

Effectiveness endpoint

Time frame · 24 weeks

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

Effectiveness endpoint

Time frame · 24 weeks

Change and percentage of fat mass at 24 weeks of treatment

Effectiveness endpoint

Time frame · 24 weeks

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

Safety endpoint

Time frame · 24 weeks

Numbers of adverse events during treatment (TEAE)

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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 locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

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