Efficacy and Safety of Tirzepatide for Weight Management

NCT06918405 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 59.127.1557.013.19.PG.2025/337
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if tirzepatide helps people manage their weight safely. It will include adults in Bangladesh who are overweight or obese, with or without type 2 diabetes. The main questions it aims to answer are: Does tirzepatide help people lose weight? What side effects do people experience while taking tirzepatide? All participants will: Receive tirzepatide as a weekly injection, starting at 2.5 mg and gradually increasing to 15 mg. Continue the treatment for 52 weeks (12 months). Visit the clinic for regular checkups and tests. Researchers will measure changes in body weight, BMI, waist size, blood sugar, blood pressure, and cholesterol levels. They will also track any side effects and assess the participants' overall health and quality of life during the study.

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

Obesity; Tirzepatide; Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Change in body weight (kg)

  Change in body weight (kg) \[5%, 10%, 15% and 20%\] from baseline at week 0 to week 52

  52 weeks

Secondary Outcomes (11)

• Change in BMI

  52 weeks

• Change in Waist circumference

  52 weeks

• Change in HbA1c

  52 weeks

• Change in fasting plasma glucose

  52 weeks

• Change in blood pressure

  52 weeks

Study Arms (1)

Tirzepatide arm

EXPERIMENTAL

All the included patients in both the diabetic and nondiabetic groups will receive the same intervention of tirzepatide at a dose of 15 mg administered subcutaneously once a week in addition to lifestyle modification. Initially, tirzepatide will be started with a dose of 2.5 mg once weekly subcutaneous injection for the first 4 weeks. After the stabilization period of the drug, the dose will be increased to 5 mg after 4 weeks, 7.5 mg after 8 weeks, 10 mg after 12 weeks, 12.5 mg after 16 weeks and finally 15 mg after 20 weeks.

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

All the included patients in both the diabetic and nondiabetic groups will receive the same intervention of tirzepatide at a dose of 15 mg administered subcutaneously once a week in addition to lifestyle modification. Initially, tirzepatide will be started with a dose of 2.5 mg once weekly subcutaneous injection for the first 4 weeks. After the stabilization period of the drug, the dose will be increased to 5 mg after 4 weeks, 7.5 mg after 8 weeks, 10 mg after 12 weeks, 12.5 mg after 16 weeks and finally 15 mg after 20 weeks.

Tirzepatide arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent will be obtained before any trial-related activities.
• Male or female, aged ≥18 years at the time of signing the informed consent form.
• Have a history of at least one self-reported unsuccessful dietary effort to lose body weight.
• Body mass index (BMI):
• ≥30 kg/m² with or without any weight-related comorbidities or
• ≥25-29.9 kg/m² with the presence of at least one of the following weight-related comorbidities (treated or untreated):
• Hypertension (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg or currently taking antihypertensive medication).
• Dyslipidemia (treated or with low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) \<40 mg/dL (1.0 mmol/L) for men or HDL \<50 mg/dL (1.3 mmol/L) for women).
• Obstructive sleep apnea.
• Cardiovascular disease (more than three months).
• In the investigator's opinion, are well-motivated, capable, and willing to:
• Learn how to self-inject study drug, as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject study drug; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject study drug).
• Inject study drug (or receive an injection from a trained individual if visually impaired or with physical limitations).
• Follow study procedures for the duration of the study, including, but not limited to, following lifestyle advice (for example, dietary restrictions and exercise plan) and maintaining a study diary.
• Male participants:

You may not qualify if:

• Medical criteria:
• Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
• A self-reported reduction in body weight of more than 5 kg within 30 days before screening, irrespective of medical records.
• Treatment with any medication for the indication of obesity within the past 90 days before screening (e.g., Orlistat, liraglutide, naltrexone/bupropion, diethylpropion, phendimetrazine, semaglutide, and setmelanotide).
• Any previous obesity treatment with surgery or a weight loss device during a lifetime.
• Continued treatment with other GLP-1 agonists, SGLT-2 inhibitors, and/or metformin. However, if these drugs can be stopped based on the best clinical judgment of the investigator, the patient can be recruited after stopping the drug and a washout period of two weeks. In the case of tirzepatide, the washout period will be 8 weeks.
• Are receiving or have received within 3 months prior to screening chronic (\>2 weeks or 14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) or have evidence of a significant, active autoimmune abnormality (for example, lupus or rheumatoid arthritis).
• Have current or history of (within 3 months prior to enrollment) treatment with medications that may cause significant weight gain, including but not limited to tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.
• Have started implantable or injectable contraceptives (such as Depo-Provera®) within 18 months prior to screening.
• Past history of pancreatitis.
• Diagnosed case of eating disorders (e.g., Bulimia nervosa).
• Patients with a previous history of suicide attempts and major depressive disorder (MDD) according to DSM-V criteria, schizophrenia, or antipsychotic drug-induced obesity.
• Patients with a personal or family history of medullary thyroid carcinoma (MTC) and/or multiple endocrine neoplasia syndrome type 2 (MEN 2).
• Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
• Have uncontrolled hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg).

Sponsors & Collaborators

• Chittagong Medical College: lead

Study Sites (1)

Chittagong Medical College Hospital

Chittagong, Bangladesh

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

BA (1)