New shot shows promise for diabetes and weight loss in india
NCT ID NCT07438444
First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This study tests tirzepatide, a once-weekly injection, in 344 Indian adults with type 2 diabetes or obesity. Over 46 weeks, researchers will check for serious side effects and measure weight loss and blood sugar control. The goal is to see if this drug is safe and effective for this population.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tirzepatide (a once-weekly injection that helps control blood sugar and reduce weight)
- What this could lead to
- If successful, this could confirm tirzepatide as a safe and effective option for managing type 2 diabetes and obesity in Indian adults.
- What could go wrong
- This is an open-label, single-arm study with no placebo group, so results may be less reliable. Side effects like nausea or diarrhea are possible, and long-term benefits beyond 46 weeks are not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 344 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2026
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
AIIMS, Bhubaneshwar
Bhubaneswar, 751019, India
-
All India Institute of Medical Sciences
Raipur, 492099, India
-
Apollo Excelcare Hospital
Guwahati, 781033, India
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B. J. Medical College & Civil Hospital
Ahmedabad, 380 016, India
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Brij Medical Centre Private Limited
Kanpur, 208020, India
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Eternal Heart Care Center and Research Institute
Jaipur, 302017, India
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Government Medical College, Kozhikode
Kozhikode, 673008, India
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Gujarat Endocrine Center
Ahmedabad, 380052, India
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ILS Hospitals
Kolkata, 700064, India
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Jawahar Lal Nehru Medical College
Ajmer, 305001, India
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K care Hospital
Kanpur, 208001, India
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King George Hospital, Andhra Medical College
Visakhapatnam, 530002, India
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Kovai Diabetes Speciality Center and Hospital
Coimbatore, 641009, India
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Lifecare Hospital and Research Centre
Bengaluru, 560092, India
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Motilal Nehru Medical College Hospital
Allahābād, 211002, India
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Osmania Medical College & Hospital
Hyderabad, 500012, India
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Sahyadri Super Speciality Hospital
Pune, 411004, India
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Shri Krishna Hrudayalaya & Critical Care Centre
Nagpur, 440012, India
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Sri Ramachandra MedicaL College & Research Institute
Chennai, 600116, India
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V.S. General Hospital
Ahmedabad, 380006, India
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Wockhardt Hospitals
Mumbai, 400011, India
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