Clinical trial NCT05931380: A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Keywords: Overweight
Metabolism and Nutrition Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Percent Change in Body Weight
timeFrame: Baseline, Week 72
measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction
timeFrame: Baseline to Week 72
Secondary outcomes:
measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction
timeFrame: Baseline to Week 72
measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction
timeFrame: Baseline to Week 72
measure: Percentage of Participants Who Achieve ≥20% Body Weight Reduction
timeFrame: Baseline to Week 72
measure: Mean Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 72
measure: Percentage of Participants Who Had Improvements in Hypertension
timeFrame: Baseline to Week 72
measure: Percentage of Participants Who Had Improvements in Dyslipidemia (only for participants with Dyslipidemia at baseline)
timeFrame: Baseline to Week 72
measure: Percentage of Participants Who Achieve HbA1c Target value (<6.5% (48 mmol/mol) at Week 72 (only T2D at Baseline):
timeFrame: Baseline to Week 72
measure: Mean Change from Baseline in Visceral Adipose Tissue (VAT)
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Waist Circumference at Umbilical Level
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in non-High Density Lipoprotein (HDL)
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in HDL
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Triglycerides
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Fasting Glucose
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in High-sensitivity C-reactive Protein
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores
timeFrame: Baseline, Week 72
measure: Mean Change from Baseline in IMPACT of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function, Physical, and Psychosocial Composite Score
timeFrame: Baseline, Week 72
measure: Time to Onset of Type 2 Diabetes (T2D) (only non T2D at Baseline)
timeFrame: Baseline to Week 72
measure: Pharmacokinetics (PK): Plasma Concentration of Orforglipron
timeFrame: Baseline to Week 72
Other outcomes:
Locations:
city: Naka
country: Japan
facility: Nishiyamadou Keiwa Hospital
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Tsuchiura Beryl Clinic
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Ohishi Internal Medicine Clinic
state: Ibaraki
city: Kamakura-shi
country: Japan
facility: Takai Internal Medicine Clinic
state: Kanagawa
city: Kamakura
country: Japan
facility: Shonan Takai Clinic
state: Kanagawa
city: Sagamihara
country: Japan
facility: Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic
state: Kanagawa
city: Kashiwara
country: Japan
facility: Shiraiwa Medical Clinic
state: Osaka
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Kawaguchi
country: Japan
facility: Sugiura Clinic
state: Saitama
city: Chiyoda
country: Japan
facility: Yotsuya Medical Cube
state: Tokyo
city: Chuo-ku
country: Japan
facility: Nihonbashi Sakura Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Heishinkai Medical Group ToCROM Clinic
state: Tokyo
city: Hiroshima
country: Japan
facility: Hiroshima Station Clinic
city: Osaka
country: Japan
facility: Osaka Nishiumeda Clinic
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: