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Once-Daily pill shows promise for obesity in japanese patients

NCT ID NCT05931380

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests an experimental once-daily oral drug called orforglipron in Japanese adults with obesity and related health problems like high blood pressure or type 2 diabetes. Participants receive either orforglipron or a placebo for 72 weeks. The main goals are to measure weight loss and the percentage of people who lose at least 5% of their body weight.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental oral drug called orforglipron
What this could lead to
If successful, this could provide a convenient once-daily pill for significant weight loss in people with obesity and related health conditions.
What could go wrong
This is a phase 3 trial, but results may not apply to non-Japanese populations. Side effects and long-term safety are still being evaluated.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

238 people

The number who actually took part.

Started

Jul 2023

Finished

Jun 2025

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 a BMI ≥27 kg/m² and \<35 kg/m² and at least 2 obesity-related health problems (treated or untreated), OR a BMI ≥35 kg/m² and at least 1 obesity-related health problem (treated or untreated). At least one obesity-related health problem should be hypertension, dyslipidemia or T2D (approximately 25% of participants). * Have a history of at least one self-reported unsuccessful dietary effort to lose body weight. * Males and females may participate in this trial. Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed. * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * No male contraception is required except in compliance with specific local government study requirements. Exclusion Criteria: * For participants with Type 2 Diabetes (T2D): * Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D. * Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within the 180 days prior to screening. * Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m², calculated by Japanese Society of Nephrology coefficient-modified chronic kidney disease-epidemiology equation during screening. * Have a known clinically significant gastric emptying abnormality. * For participants without Type 2 diabetes (T2D): Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %. * Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening. * Have chronic kidney disease. * Have lupus or rheumatoid arthritis. * Have the following cardiovascular conditions within 90 days prior to screening. * Have acute or chronic hepatitis.

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Conditions

The condition(s) this trial relates to.

nutritional disorder Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

Contacts and locations

Locations

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031, Japan

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, Tokyo, 160-0008, Japan

  • Hiroshima Station Clinic

    Hiroshima, 732-0053, Japan

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka, 565-0853, Japan

  • Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic

    Sagamihara, Kanagawa, 252-0302, Japan

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo, 103-0025, Japan

  • Nishiyamadou Keiwa Hospital

    Naka, Ibaraki, 311-0133, Japan

  • Ohishi Internal Medicine Clinic

    Tsuchiura, Ibaraki, 300-0835, Japan

  • Osaka Nishiumeda Clinic

    Osaka, 530-0001, Japan

  • Shiraiwa Medical Clinic

    Kashihara, Osaka, 582-0005, Japan

  • Shonan Takai Clinic

    Kamakura, Kanagawa, 247-0055, Japan

  • Sugiura Clinic

    Kawaguchi, Saitama, 332-0012, Japan

  • Takai Internal Medicine Clinic

    Kamakura-shi, Kanagawa, 247-0056, Japan

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo, 103-0027, Japan

  • Tsuchiura Beryl Clinic

    Tsuchiura, Ibaraki, 300-0062, Japan

  • Yotsuya Medical Cube

    Chiyoda City, Tokyo, 102-0084, Japan

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