Phase
Condition
Obesity
Diabetes Prevention
Treatment
Orforglipron
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with a BMI ≥27 kg/m² and <35 kg/m² and at least 2 obesity-relatedhealth problems (treated or untreated), OR a BMI ≥35 kg/m² and at least 1obesity-related health problem (treated or untreated). At least one obesity-relatedhealth problem should be hypertension, dyslipidemia or T2D (approximately 25% ofparticipants).
Have a history of at least one self-reported unsuccessful dietary effort to losebody weight.
Males and females may participate in this trial. Female participants must not bepregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.
Contraceptive use by participants should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.
No male contraception is required except in compliance with specific localgovernment study requirements.
Exclusion
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 ofhypoglycemia unawareness within the 180 days prior to screening.
Have renal impairment measured as estimated glomerular filtration rate (eGFR) <15mL/min/1.73 m², calculated by Japanese Society of Nephrology coefficient-modifiedchronic 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 withhemoglobin A1c (HbA1c) ≥6.5 %.
Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior toscreening.
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.
Study Design
Connect with a study center
Nishiyamadou Keiwa Hospital
Naka, Ibaraki 311-0133
JapanSite Not Available
Ohishi Internal Medicine Clinic
Tsuchiura, Ibaraki 300-0835
JapanSite Not Available
Tsuchiura Beryl Clinic
Tsuchiura, Ibaraki 300-0062
JapanSite Not Available
Shonan Takai Clinic
Kamakura, Kanagawa 247-0055
JapanSite Not Available
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa 247-0056
JapanSite Not Available
Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic
Sagamihara, Kanagawa 252-0302
JapanSite Not Available
Shiraiwa Medical Clinic
Kashiwara, Osaka 582-0005
JapanSite Not Available
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka 565-0853
JapanSite Not Available
Sugiura Clinic
Kawaguchi, Saitama 332-0012
JapanSite Not Available
Yotsuya Medical Cube
Chiyoda, Tokyo 102-0084
JapanSite Not Available
Fukuwa Clinic
Chuo-ku, Tokyo 104-0031
JapanSite Not Available
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo 103-0025
JapanSite Not Available
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo 103-0027
JapanSite Not Available
Heishinkai Medical Group ToCROM Clinic
Shinjuku-ku, Tokyo 160-0008
JapanSite Not Available
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo 160-0008
JapanActive - Recruiting
Hiroshima Station Clinic
Hiroshima, 732-0053
JapanSite Not Available
AMC Nishiumeda Clinic
Osaka, 530-0001
JapanSite Not Available
Osaka Nishiumeda Clinic
Osaka, 530-0001
JapanSite Not Available
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