NCT05931380CompletedPhase 3
A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease
A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Japanese Adult Participants With Obesity Disease
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
The main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 238 (actual)
- First submitted
- 27 Jun 2023
- Start date
- 31 Jul 2023
- Primary completion date
- 19 Jun 2025
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity
- NCT number
- NCT05931380
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 238
- From 31 Jul 2023 to the primary completion date, 19 Jun 2025
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
- Have the following cardiovascular conditions within 90 days prior to screening.
Other illness
- Have chronic kidney disease.
- Have acute or chronic hepatitis.
Lab values
- 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.
- For participants without Type 2 diabetes (T2D): Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %.
Other
- Have a known clinically significant gastric emptying abnormality.
- Have lupus or rheumatoid arthritis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yotsuya Medical Cube Coordinator of this site? Confirm its status | Chiyoda City | Japan | Unknown status |
| Nihonbashi Sakura Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Fukuwa Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Tokyo-Eki Center-building Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Hiroshima Station Clinic Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Shonan Takai Clinic Coordinator of this site? Confirm its status | Kamakura | Japan | Unknown status |
| Takai Internal Medicine Clinic Coordinator of this site? Confirm its status | Kamakura-shi | Japan | Unknown status |
| Shiraiwa Medical Clinic Coordinator of this site? Confirm its status | Kashihara | Japan | Unknown status |
| Sugiura Clinic Coordinator of this site? Confirm its status | Kawaguchi | Japan | Unknown status |
| Nishiyamadou Keiwa Hospital Coordinator of this site? Confirm its status | Naka | Japan | Unknown status |
| Osaka Nishiumeda Clinic Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic Coordinator of this site? Confirm its status | Sagamihara | Japan | Unknown status |
| Heishinkai Medical Group ToCROM Clinic Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Medical Corporation Heishinkai OCROM Clinic Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Tsuchiura Beryl Clinic Coordinator of this site? Confirm its status | Tsuchiura | Japan | Unknown status |
| Ohishi Internal Medicine Clinic Coordinator of this site? Confirm its status | Tsuchiura | Japan | Unknown status |
Related publications
- Efficacy and safety of oral orforglipron in Japanese participants with obesity disease (ATTAIN-J): a double-blind, randomised, placebo-controlled, parallel-group, phase 3 trial.Lancet Diabetes Endocrinol · 2026 · PMID 42962687
This page is information, not medical advice. Discuss any trial with your doctor.