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Not yet recruitingPhase 2

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

0

Recruiting sites

-

Estimated enrollment

60

Study population

Obesity / overweight

Eligibility highlights

BMI 28-40

Primary endpoint

Lean body mass

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07671391
Org study IDZSJZ2026

Timeline

Milestones

Study first posted2026-06-26actual
Last update posted2026-06-26actual
Study start2026-08estimated (month precision)
Primary completion2027-07estimated (month precision)
Study completion2027-12estimated (month precision)

Assets

Investigational agents

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
5
Safety / tolerability / PK
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Safety endpoint

Time frame:24 weeks

descriptive

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

The percentage change in lean body mass

Time frame:24 weeks

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Effectiveness endpoint

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Effectiveness endpoint

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Effectiveness endpoint

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Effectiveness endpoint

Time frame:24 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.