Once-Daily pill shows promise for obesity in japanese patients
NCT ID NCT05931380
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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238 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Jun 2025
- 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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
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Heishinkai Medical Group ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008, Japan
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Hiroshima Station Clinic
Hiroshima, 732-0053, Japan
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Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853, Japan
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Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic
Sagamihara, Kanagawa, 252-0302, Japan
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Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, 103-0025, Japan
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Nishiyamadou Keiwa Hospital
Naka, Ibaraki, 311-0133, Japan
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Ohishi Internal Medicine Clinic
Tsuchiura, Ibaraki, 300-0835, Japan
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Osaka Nishiumeda Clinic
Osaka, 530-0001, Japan
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Shiraiwa Medical Clinic
Kashihara, Osaka, 582-0005, Japan
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Shonan Takai Clinic
Kamakura, Kanagawa, 247-0055, Japan
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Sugiura Clinic
Kawaguchi, Saitama, 332-0012, Japan
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Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, 247-0056, Japan
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Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027, Japan
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Tsuchiura Beryl Clinic
Tsuchiura, Ibaraki, 300-0062, Japan
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Yotsuya Medical Cube
Chiyoda City, Tokyo, 102-0084, Japan
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