DelfaGLP-1 Atlas

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Not yet recruiting

Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)

A Study of Real-World Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM) in Bangladesh

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

3

Recruiting sites

—

Enrollment

364

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥25

Primary endpoints

•Body weight, % change•Discontinuation due to AE

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 IDNCT07099742
Org study IDBex-2502004

Timeline

Milestones

Study first posted2025-08-01actual
Last update posted2025-08-03actual
Study start2025-09estimated (month precision)
Primary completion2026-04estimated (month precision)
Study completion2026-07estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodProbability sample

Study population text

The study population will include adult males and females aged 18 years and older who are clinically diagnosed with obesity, with or without Type 2 Diabetes Mellitus. Eligible participants are those who have been prescribed Tirzepatide (2.5 mg, 5 mg, or 7.5 mg) administered subcutaneously once weekly, or who are undergoing structured lifestyle interventions involving extensive exercise and dietary control. Only patients meeting all inclusion criteria and none of the exclusion criteria will be enrolled in the study.

Inclusion criteria

•Adult patients of both sexes, aged ≥18 years.
•Body mass index (BMI) ≥25 kg/m².
•Naïve to glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy.
•Self-reported stable body weight (change ≤5 kg) over the past 3 months.

Exclusion criteria

•Diagnosis of diabetes other than Type 2 Diabetes Mellitus.
•History of chronic or acute pancreatitis.
•Presence of acute medical conditions, including acute hepatitis, myocardial infarction, stroke, heart failure, febrile illness, or acute diarrheal disease.
•Evidence of significant, uncontrolled endocrine disorders (e.g., Cushing's syndrome, thyroid disorders, adrenal insufficiency, congenital adrenal hyperplasia).
•History or presence of malignancy.
•Active gallbladder disease.
•Female participants who are pregnant, breastfeeding, planning pregnancy, or of childbearing potential, not using adequate contraceptive methods.
•Prior or planned surgical treatment for obesity.
•Use of weight-loss products (including prescription medications, over-the-counter drugs, or herbal preparations) within 3 months prior to screening.

Endpoints (11)

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

Safety / tolerability / PK
5
Weight & body composition
4
Glycemic / diabetes
2

Weight & body composition

4 endpoints
Primary/protocol endpoint

Percentage change in body weight at Week 24 in both treatment groups.

Time frame:Baseline to 24 Weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in body weight at Week 24 across both treatment groups

Time frame:Baseline to 24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Body Mass Index (BMI) and waist circumference at Week 24 across both treatment groups

Time frame:Baseline to Week 24

change from baseline, improvement

componentsBMI, change, Waist circumference, change

Secondary/protocol endpoint

Percentage of participants achieving ≥15% reduction in body weight from baseline to Week 24

Time frame:Baseline to Week 24

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Percent change from baseline in Hemoglobin A1c (HbA1c) at Week 24

Time frame:Baseline to Week 24

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of diabetic participants achieving HbA1c <7% at Week 24

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

Percentage of participants withdrawn from the study due to adverse events by Week 24

Time frame:Up to Week 24

Discontinuation due to AE

threshold achievement, event

Secondary/protocol endpoint

Percentage of participants achieving the highest dose of Tirzepatide by Week 24

Time frame:Up to Week 24

threshold achievement, descriptive

Secondary/protocol endpoint

Frequency of adverse events (AEs) and serious adverse events (SAEs) reported by Week 24

Time frame:Up to Week 24

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Number of hypoglycemic events reported by Week 24

Time frame:Up to Week 24

event count, event

Secondary/protocol endpoint

Number of self-reported gastrointestinal (GI) adverse events by Week 24

Time frame:Up to Week 24

event count, event

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.