A Phase 4, Open-Label, Single-Arm, 46-Week Study to Investigate the Safety and Efficacy With Tirzepatide in Adult Indian Participants With Either Type 2 Diabetes or Obesity
Study of Tirzepatide for Diabetes and Obesity in India
Plain English Summary
A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity is a Phase 4 clinical trial sponsored by Eli Lilly and Company studying Diabetes Mellitus, Type 2, Obesity, Overweight. This study tests the safety and effectiveness of a drug called Tirzepatide. It is for adults in India who have type 2 diabetes or who are overweight or obese. Participants will receive Tirzepatide for about 46 weeks and will be closely monitored. Alternative treatments include lifestyle changes, other medications, and surgery for obesity. The trial aims to enroll 344 participants.
Official Summary
The main purpose of this study is to measure the safety and efficacy of tirzepatide in adult participants in India who have type 2 diabetes or who have obesity or overweight without type 2 diabetes. Participation in the study will last about 46 weeks.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults in India with type 2 diabetes who have not used insulin and have specific blood sugar levels (HbA1c) and BMI. Adults in India who are overweight (BMI >= 27) or obese (BMI >= 30) and may have related health issues like high blood pressure or heart disease, but do not have type 2 diabetes. People with type 1 diabetes, recent heart problems (heart attack, stroke, hospitalization for heart failure), or severe heart failure cannot join. Individuals with type 2 diabetes who are considering weight loss surgery or have had significant weight changes recently are also excluded. This trial is studying Diabetes Mellitus, Type 2, Obesity, Overweight, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the safety of Tirzepatide by tracking any serious side effects that the doctor believes are related to the study drug. The specific primary outcome measures are: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration (Baseline through Week 46). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial addresses the significant need for effective treatments for type 2 diabetes and obesity in India, aiming to improve patient outcomes and quality of life. This research targets Diabetes Mellitus, Type 2, Obesity, Overweight, where improved treatment options are needed.
Investor Insight
This Phase 4 trial for Tirzepatide, a potentially significant drug for diabetes and obesity, signals continued investment in understanding its long-term safety and efficacy in a large, diverse populat This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of Tirzepatide and if this study is right for you. Participation involves regular visits to the study site for about 46 weeks to receive the medication and undergo monitoring. Be prepared for potential side effects and discuss any concerns with the study team promptly. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 344 participants
Interventions
- DRUG: Tirzepatide — Administered SC
Primary Outcomes
- Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration (Baseline through Week 46)
Secondary Outcomes
- Percentage of Participants with ≥5% Body Weight Reduction (Week 46)
- Percentage of Participants with Hemoglobin A1c (HbA1c) <7.0% in Participants with Type 2 Diabetes (Week 46)
- Change from Baseline in Waist Circumference in Participants with Obesity or Overweight (Baseline, Week 46)
Full Eligibility Criteria
Inclusion Criteria: Participants with Type 2 Diabetes: * Have had type 2 diabetes for at least one year * Insulin naive * Have HbA1c ≥7.5% and ≤10% at screening * Have body mass index (BMI) ≥23 kilograms per square meter (kg/m2) Participants with Obesity or Overweight without Type 2 Diabetes: * Have a BMI * Greater than or equal to 30 kg/m2 OR * Greater than or equal to 27 kg/m2 AND previously diagnosed with at least one of the following weight-related comorbidities: high blood pressure, lipid disorder, obstructive sleep apnea, heart disease Exclusion Criteria: Participants with Type 2 Diabetes: * Have type 1 diabetes * Have had any of the following heart conditions within 6 months prior to screening: * heart attack * stroke * hospitalization due to heart failure * Have New York Heart Association Functional Classification Class III or IV congestive heart failure (CHF) * Have type 2 diabetes along with morbid obesity and being considered for bariatric surgery or any other procedure intended for weight loss Participants with Obesity or Overweight without Type 2 Diabetes: * Have type 1 diabetes or type 2 diabetes * Have a self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 3 months prior to screening * Have a prior or planned surgical treatment for obesity * Have had any of the following heart conditions within 6 months prior to screening: * heart attack * stroke * hospitalization due to heart failure * Have New York Heart Association Functional Classification Class III or IV CHF * Have taken any medications or alternative remedies for weight loss within 3 months prior to screening
Trial Locations
- B. J. Medical College & Civil Hospital, Ahmedabad, India
- V.S. General Hospital, Ahmedabad, India
- Gujarat Endocrine Center, Ahmedabad, India
- Jawahar Lal Nehru Medical College, Ajmer, India
- Motilal Nehru Medical College Hospital, Allahabād, India
- Lifecare Hospital and Research Centre, Bengaluru, India
- AIIMS, Bhubaneshwar, Bhubaneswar, India
- Sri Ramachandra MedicaL College & Research Institute, Chennai, India
- Kovai Diabetes Speciality Center and Hospital, Coimbatore, India
- Apollo Excelcare Hospital, Guwahati, India
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT07438444?
NCT07438444 is a Phase 4 INTERVENTIONAL study titled "A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity." It is currently not yet recruiting and is sponsored by Eli Lilly and Company. The trial targets enrollment of 344 participants.
What conditions does NCT07438444 study?
This trial investigates treatments for Diabetes Mellitus, Type 2, Obesity, Overweight. The primary condition under study is Diabetes Mellitus, Type 2.
What treatments are being tested in NCT07438444?
The interventions being studied include: Tirzepatide (DRUG). Administered SC
What does Phase 4 mean for NCT07438444?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT07438444?
This trial is currently "Not Yet Recruiting." It started on 2026-03. The estimated completion date is 2027-10.
Who is sponsoring NCT07438444?
NCT07438444 is sponsored by Eli Lilly and Company. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07438444?
The trial aims to enroll 344 participants. The trial has not yet started recruiting.
How is NCT07438444 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07438444?
The primary outcome measures are: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration (Baseline through Week 46). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07438444 being conducted?
This trial is being conducted at 20 sites, including Ahmedabad; Ajmer; Allahabād; Bengaluru and 16 more sites (India).
Where can I find official information about NCT07438444?
The official record for NCT07438444 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07438444. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07438444 testing in simple terms?
This study tests the safety and effectiveness of a drug called Tirzepatide. It is for adults in India who have type 2 diabetes or who are overweight or obese.
Why is this trial significant?
This trial addresses the significant need for effective treatments for type 2 diabetes and obesity in India, aiming to improve patient outcomes and quality of life.
What are the potential risks of participating in NCT07438444?
The most important risk is any serious side effect that the doctor believes is caused by the study drug. Common side effects may include nausea, vomiting, diarrhea, constipation, and abdominal pain. Specific risks related to diabetes and obesity management will be monitored. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07438444?
Ask your doctor about the potential benefits and risks of Tirzepatide and if this study is right for you. Participation involves regular visits to the study site for about 46 weeks to receive the medication and undergo monitoring. Be prepared for potential side effects and discuss any concerns with the study team promptly. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07438444 signal from an investment perspective?
This Phase 4 trial for Tirzepatide, a potentially significant drug for diabetes and obesity, signals continued investment in understanding its long-term safety and efficacy in a large, diverse populat This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive Tirzepatide for about 46 weeks and will be closely monitored. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.