DelfaGLP-1 Atlas

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TRZ

WithdrawnPhase 4

Effects of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity

Effect of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

—

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 30-42•HbA1c ≤6.4%

Primary endpoint

•Body weight, % change

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 IDNCT06009653
Org study ID202209182
Secondary IDP50MD017344

Timeline

Milestones

Study first posted2023-08-24actual
Study start2023-09-13actual
Primary completion2024-05-29actual
Study completion2024-05-29actual
Last update posted2025-02-25actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age21 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Self-reported Hispanic and/or Latino heritage
•Body Mass Index (BMI) 30-42 kg/m²
•HbA1c ≤ 6.4%

Exclusion criteria

•Previous diagnosis of diabetes or fasting glucose ≥ 126 mg/dl or 2 hr oral glucose tolerance test plasma glucose ≥ 200 mg/dl
•Unstable weight (≥4% during the last 2 months prior to study enrollment)
•CPAP treatment for obstructive sleep apnea
•Severe cardiovascular disease within the 6 months prior to study enrollment
•Severe organ system dysfunction
•Known clinically significant gastric emptying abnormality
•History of chronic or acute pancreatitis
•Thyroid-stimulating hormone (TSH) >1.5X the upper limit of normal
•Medical conditions that cause obesity
•History of significantly active or unstable Major Depressive Disorder or other severe psychiatric disorder within the last 2 months
•Active substance abuse with alcohol or drugs
•Uncontrolled hypertension
•Liver disease
•Calcitonin level of ≥20 ng/L if eGFR ≥60 mL/min/1.73 m2 or ≥35 ng/L if eGFR <60 mL/min/1.73 m2
•Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
•History of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
•Severe anemia
•Pregnant or breastfeeding
•Metal implants that preclude MRI testing
•Use of medications that are known to affect the study outcome measures
•Do not agree to use contraception throughout the study period in male and female participants of reproductive and childbearing age
•Persons who are not able to grant voluntary informed consent
•Unable or unwilling to follow the study protocol
•Have any other condition not listed in this section (e.g. hypersensitivity or intolerance) that is a contraindication of GLP-1R agonists

Endpoints (35)

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
12
Other clinical outcomes
8
Glycemic / diabetes
4
Cardiometabolic biomarkers
4
MASH / liver
2
Patient-reported / QoL
2
Safety / tolerability / PK
2
Other (unclassified)
1

Weight & body composition

12 endpoints
Primary/protocol endpoint

Change in body weight

Time frame:After 24 weeks of intervention

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Change in body weight

Time frame:After 52 weeks of intervention

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of participants losing at least 5% in body weight

Time frame:After 24 weeks of intervention

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants losing at least 5% in body weight

Time frame:After 52 weeks of intervention

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants losing at least 10% in body weight

Time frame:After 24 weeks of intervention

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants losing at least 10% in body weight

Time frame:After 52 weeks of intervention

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants losing at least 15% in body weight

Time frame:After 24 weeks of intervention

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants losing at least 15% in body weight

Time frame:After 52 weeks of intervention

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Fat mass and fat free mass

Time frame:Before and after 24 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint

Fat mass and fat free mass

Time frame:Before and after 52 weeks of intervention

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Intra-abdominal fat mass and intrahepatic triglyceride content

Time frame:Before and after 52 weeks of intervention

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Grip strength

Time frame:Before and after 52 weeks of intervention

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint/low confidence

β-cell function

Time frame:Before and after 24 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint/low confidence

β-cell function

Time frame:Before and after 52 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Insulin clearance

Time frame:Before and after 24 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Insulin clearance

Time frame:Before and after 52 weeks of intervention

descriptive

MASH / liver

2 endpoints
Secondary/protocol endpoint

Liver fat

Time frame:Before and after 24 weeks of intervention

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Liver fat

Time frame:Before and after 52 weeks of intervention

Liver fat content, change

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint/low confidence

Plasma lipids

Time frame:Before and after 24 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint

Plasma lipids

Time frame:Before and after 52 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint

Blood pressure

Time frame:Before and after 24 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint

Blood pressure

Time frame:Before and after 52 weeks of intervention

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Program acceptability from community health workers and study participants

Time frame:After 24 weeks of intervention

descriptive

Secondary/protocol endpoint

Program acceptability from community health workers and study participants

Time frame:After 52 weeks of intervention

descriptive

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Drug/placebo adherence

Time frame:After 24 weeks of intervention

descriptive

Secondary/protocol endpoint

Drug/placebo adherence

Time frame:After 52 weeks of intervention

descriptive

Other clinical outcomes

8 endpoints
Secondary/protocol endpoint/low confidence

Sleep quality

Time frame:Before and after 24 weeks of intervention

descriptive

Secondary/protocol endpoint/low confidence

Sleep quality

Time frame:Before and after 52 weeks of intervention

descriptive

Secondary/protocol endpoint

Sleep quantity

Time frame:Before and after 24 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint

Sleep quantity

Time frame:Before and after 52 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint

Physical performance

Time frame:Before and after 24 weeks of intervention

change from baseline, improvement

components50ft walk time seconds, five times sit to stand time seconds

Secondary/protocol endpoint

Physical performance

Time frame:Before and after 52 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint

Grip strength

Time frame:Before and after 24 weeks of intervention

change from baseline, improvement

Secondary/protocol endpoint

Lifestyle program adherence

Time frame:After 52 weeks of intervention

event count, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Lifestyle program adherence

Time frame:After 24 weeks of intervention

descriptive

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.