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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

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Yotsuya Medical Cube
Coordinator of this site? Confirm its status
Chiyoda CityJapanUnknown status
Nihonbashi Sakura Clinic
Coordinator of this site? Confirm its status
Chuo-kuJapanUnknown status
Fukuwa Clinic
Coordinator of this site? Confirm its status
Chuo-kuJapanUnknown status
Tokyo-Eki Center-building Clinic
Coordinator of this site? Confirm its status
Chuo-kuJapanUnknown status
Hiroshima Station Clinic
Coordinator of this site? Confirm its status
HiroshimaJapanUnknown status
Shonan Takai Clinic
Coordinator of this site? Confirm its status
KamakuraJapanUnknown status
Takai Internal Medicine Clinic
Coordinator of this site? Confirm its status
Kamakura-shiJapanUnknown status
Shiraiwa Medical Clinic
Coordinator of this site? Confirm its status
KashiharaJapanUnknown status
Sugiura Clinic
Coordinator of this site? Confirm its status
KawaguchiJapanUnknown status
Nishiyamadou Keiwa Hospital
Coordinator of this site? Confirm its status
NakaJapanUnknown status
Osaka Nishiumeda Clinic
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic
Coordinator of this site? Confirm its status
SagamiharaJapanUnknown status
Heishinkai Medical Group ToCROM Clinic
Coordinator of this site? Confirm its status
Shinjuku-kuJapanUnknown status
Medical Corporation Heishinkai OCROM Clinic
Coordinator of this site? Confirm its status
Suita-shiJapanUnknown status
Tsuchiura Beryl Clinic
Coordinator of this site? Confirm its status
TsuchiuraJapanUnknown status
Ohishi Internal Medicine Clinic
Coordinator of this site? Confirm its status
TsuchiuraJapanUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.