New shot shows promise for diabetes and weight loss in india

NCT ID NCT07438444

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

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

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

  • B. J. Medical College & Civil Hospital

    Ahmedabad, 380 016, India

  • Brij Medical Centre Private Limited

    Kanpur, 208020, India

  • Eternal Heart Care Center and Research Institute

    Jaipur, 302017, India

  • Government Medical College, Kozhikode

    Kozhikode, 673008, India

  • Gujarat Endocrine Center

    Ahmedabad, 380052, India

  • ILS Hospitals

    Kolkata, 700064, India

  • Jawahar Lal Nehru Medical College

    Ajmer, 305001, India

  • K care Hospital

    Kanpur, 208001, India

  • King George Hospital, Andhra Medical College

    Visakhapatnam, 530002, India

  • Kovai Diabetes Speciality Center and Hospital

    Coimbatore, 641009, India

  • Lifecare Hospital and Research Centre

    Bengaluru, 560092, India

  • Motilal Nehru Medical College Hospital

    Allahābād, 211002, India

  • Osmania Medical College & Hospital

    Hyderabad, 500012, India

  • Sahyadri Super Speciality Hospital

    Pune, 411004, India

  • Shri Krishna Hrudayalaya & Critical Care Centre

    Nagpur, 440012, India

  • Sri Ramachandra MedicaL College & Research Institute

    Chennai, 600116, India

  • V.S. General Hospital

    Ahmedabad, 380006, India

  • Wockhardt Hospitals

    Mumbai, 400011, India

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