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New treatment option for Diabetes Mellitus, Type 2
Official title A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity
ClinicalTrials.gov ID: NCT07438444
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for diabetes mellitus, type 2.
Also referred to as LY3298176.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ahmedabad, India
- Ajmer, India
- Allahābād, India
- Bengaluru, India
- Bhubaneswar, India
- Chennai, India
- Coimbatore, India
- Guwahati, India
- Hyderabad, India
- Jaipur, India
- Kanpur, India
- Kolkata, India
- Kozhikode, India
- Mumbai, India
- Nagpur, India
- Pune, India
- Raipur, India
- Visakhapatnam, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ahmedabad, India; Ajmer, India; Allahābād, India; Bengaluru, India; Bhubaneswar, India; Chennai, India and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.