Diabetes Mellitus, Type 2Phase 4NCT07438444
A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity
A Phase 4 study testing Tirzepatide in people with Diabetes Mellitus, Type 2 and Obesity, run by Eli Lilly and Company at 21 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, Overweight
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 21 sitesIndia
- Study dates
- 27 Feb 2026to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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 and contacts
21 sites in 1 country.
21 sites in 1 country
India21 sites
B. J. Medical College & Civil Hospital
Ahmedabad, 380 016
V.S. General Hospital
Ahmedabad, 380006
Gujarat Endocrine Center
Ahmedabad, 380052
Jawahar Lal Nehru Medical College
Ajmer, 305001
Motilal Nehru Medical College Hospital
Allahabād, 211002
Lifecare Hospital and Research Centre
Bengaluru, 560092
AIIMS, Bhubaneshwar
Bhubaneswar, 751019
Sri Ramachandra MedicaL College & Research Institute
Chennai, 600116
Kovai Diabetes Speciality Center and Hospital
Coimbatore, 641009
Apollo Excelcare Hospital
Guwahati, 781033
Osmania Medical College & Hospital
Hyderabad, 500012
Eternal Heart Care Center and Research Institute
Jaipur, 302017
K care Hospital
Kanpur, 208001
Brij Medical Centre Private Limited
Kanpur, 208020
ILS Hospitals
Kolkata, 700064
Government Medical College, Kozhikode
Kozhikode, 673008
Wockhardt Hospitals
Mumbai, 400011
Shri Krishna Hrudayalaya & Critical Care Centre
Nagpur, 440012
Sahyadri Super Speciality Hospital
Pune, 411004
All India Institute of Medical Sciences
Raipur, 492099
King George Hospital, Andhra Medical College
Visakhapatnam, 530002
About this study
Official title: 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
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.
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Overweight
- Being tested
- Tirzepatide
- Keywords
- Type 2 Diabetes in India, Obesity in India, Obese in India, Tirzepatide, Tirzepatide in India
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Participants will receive tirzepatide subcutaneously (SC) Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Week 46
Secondary outcomes (3)
Percentage of Participants with ≥5% Body Weight Reduction
Measured: Week 46
Percentage of Participants with Hemoglobin A1c (HbA1c) <7.0% in Participants with Type 2 Diabetes
Measured: Week 46
Change from Baseline in Waist Circumference in Participants with Obesity or Overweight
Measured: Baseline, Week 46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start27 Feb 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438444
- Sponsor's protocol ID
- 27235
- Other IDs
- I8F-IN-GPIZ
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07438444
- Acronym / sponsor ID
- 27235
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Overweight
- Keywords
- Type 2 Diabetes in India, Obesity in India, Obese in India, Tirzepatide, Tirzepatide in India
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideParticipants will receive tirzepatide subcutaneously (SC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
- Have a BMI
Key exclusion criteria (18 listed)
- Have type 1 diabetes
- Have had any of the following heart conditions within 6 months prior to screening:
- 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
- Have type 1 diabetes or type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC | Drug | Tirzepatide |
Primary outcome
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline through Week 46
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
3 secondary outcomes
Percentage of Participants with ≥5% Body Weight Reduction
Time frame: Week 46
Percentage of Participants with Hemoglobin A1c (HbA1c) <7.0% in Participants with Type 2 Diabetes
Time frame: Week 46
Change from Baseline in Waist Circumference in Participants with Obesity or Overweight
Time frame: Baseline, Week 46
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirzepatide in people with Diabetes Mellitus, Type 2 and Obesity, run by Eli Lilly and Company at 21 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Week 46). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.