← Trials/Trial dossier/NCT05912621

RecruitingPhase 2

Tirzepatide: Reversal of Lipotoxicity and Adipose Tissue Dysfunction in Humans With Overweight/Obesity

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

66

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI 27-39.9

Primary endpoints

Adipocyte SizeAdipocyte Fat Storage CapacityTotal fat mass

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05912621
Org study ID70131

Timeline

Milestones

Study first posted2023-06-22actual
Study start2023-11-09actual
Last update posted2024-12-04actual
Primary completion2028-06estimated (month precision)
Study completion2029-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

nondiabetic as defined by fasting plasma glucose < 126 mg/dL while off all glucose lowering medications
BMI 27-39.9 kg/m2. Individuals with obesity (BMI 30-39.9 kg/m2) are not required to have an additional risk factor but those who are overweight (27-29.9 kg/m2) must have at least one weight-related factor as follows: hypertension defined as physician-diagnosed and taking antihypertensive medication or SBP> 130 or DBP > 80 mm Hg; dyslipidemia defined as physician diagnosed and taking medication or LDL > 160 mg/dL, TG > 150 mg/dL, HDL < 50 or < 40 mg/dL for women and men, respectively; prediabetes defined as fasting glucose 100-125 mg/dL off all antidiabetic or diabetogenic medications, physician diagnosed obstructive sleep apnea, non-alcoholic fatty liver disease, history of gallstones, and osteoarthritis.
Age 18-70
Pre and postmenopausal women will be eligible and details of last menstrual period and/or hormone replacement collected for statistical adjustment and formal testing for effect modification.

Exclusion criteria

prior bariatric surgery or liposuction
unstable body weight defined as self-reported weight change >2 kg over the past 6 weeks
unstable hypertension (defined as BP >160/100 mm Hg)
major organ disease
chronic inflammatory conditions
pregnancy/lactation
active malignancy undergoing treatment
use (current or within the past three months) of diabetogenic or weight loss medications, including GLP1 analogs
active eating or psychiatric disorder
heavy alcohol use (>2 drinks/day for women and > 3 drinks/day for men) will be excluded

Endpoints (4)

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

Weight & body composition
3
Glycemic / diabetes
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Change in Adipocyte Size

Time frame:Baseline and Week 22

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Adipocyte Fat Storage Capacity

Time frame:Baseline and Week 22

change from baseline, improvement

Primary/protocol endpoint

Assess changes in Regional Fat

Time frame:Baseline, week 6, and week 22

Total fat mass

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Change from baseline on the 2-stage Steady State Plasma Glucose test

Time frame:Baseline, week 6, and week 22

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.