A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease

Eli Lilly and Company267 enrolled

Overview

The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 Weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

267

Conditions

Obesity

Interventions

TirzepatideDRUG

Administered SC

PlaceboOTHER

Administered SC

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a BMI of greater than or equal to ≥27 kg/m² and \<less than 35 kg/m² with at least 2 obesity-related health problems or ≥35 kg/m² with at least 1 obesity-related health problems. Health problems are IGT, hyperlipidemia, or NAFLD. * Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria: * Have diabetes. * Acute or chronic liver disease other than NAFLD. * Have a self-reported change in body weight \>5 kg within 3 months prior to screening. * Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months. * Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<30 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. * Have had a history of chronic or acute pancreatitis. * Have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 micro units per milliliter (μIU/mL) at screening. * Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity. * Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years. * Have a cardiovascular condition within 3 months prior to randomization * Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome type 2.

Locations (18)

Kohnodai Hospital, National Center for Global Health and Medicine

Ichikawa, Chiba, Japan

Saiseikai Matsuyama Hospital

Matsuyama, Ehime, Japan

Outcomes

Primary Outcomes

Mean Percent Change in Body Weight

Mean percent change in body weight was measured. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + impaired glucose tolerance (IGT) at Screening + Hyperlipidemia at Screening + non-alcoholic fatty liver disease (NAFLD) at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, 72 Weeks

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Time frame: Week 72

Secondary Outcomes

Percentage of Participants Who Had Improvement in Obesity-related Health Problems

Percentage of participants who had improvement in obesity-related health problems

Time frame: Week 72

Change From Baseline in Fasting Glucose for Participants With IGT at Baseline

Change from Baseline in Fasting Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline

Change from Baseline in OGTT 2-hr Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline

Data from ClinicalTrials.gov

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Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, Japan

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, Japan

Motomachi Takatsuka Naika Clinic

Yokohama, Kanagawa, Japan

Osaka Saiseikai Suita hospital

Suita, Osaka, Japan

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, Japan

Takatsuki Red Cross Hospital

Takatsuki, Osaka, Japan

The Institute for Adult Disease, Asahi Life Foundation

Chuo-ku, Tokyo, Japan

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, Japan

...and 8 more locations

Percent Change from Baseline in Fasting Lipids TG for Participants with Hyperlipidemia at Baseline. LS mean was determined by MMRM model with log (Baseline) + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]

Percent Change from Baseline in HFF for participants diagnosed as NAFLD by MRI at Baseline. LS mean was determined by ANCOVA model with Baseline + Hyperlipidemia at Screening + IGT at Screening + Sex + Treatment (Type III sum of squares) as variables. Percent Change from Baseline in HFF for participants with NAFLD is reported. NAFLD was diagnosed by Magnetic Resonance Imaging (MRI) at Baseline. This was evaluated only for participants who were diagnosed with NAFLD at baseline by MRI.

Time frame: Baseline, Week 72

Percentage of Participants Who Achieved Improvements of IGT

Percentage of Participants Who Achieved Improvements of IGT. This was evaluated only for participants with IGT at baseline.

Time frame: Week 72

Percentage of Participants Who Achieved Improvements of Hyperlipidemia

Percentage of Participants Who Achieved Improvements of Hyperlipidemia. This was evaluated only for participants with hyperlipidemia at baseline.

Time frame: Week 72

Percentage of Participants Who Achieved Improvements of NAFLD

Percentage of Participants Who Achieved Improvements of NAFLD. This was evaluated only for participants who were diagnosed as NAFLD by MRI at Baseline.

Time frame: Week 72

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Percentage of Participants Who Achieve ≥10% body weight reduction.

Time frame: Week 72

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Percentage of Participants Who Achieve ≥15% body weight reduction.

Time frame: Week 72

Change From Baseline in Absolute Body Weight

Change from Baseline in Absolute Body Weight. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Change From Baseline in Body Mass Index (BMI)

Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Percent Change From Baseline in Visceral Adipose Tissue (VAT)

Percent Change from Baseline in VAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT)

Percent Change from Baseline in SAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Change From Baseline in VAT/SAT Ratio

Change from Baseline in VAT/SAT Ratio. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline

Percentage of Participants Who Achieve VAT \<100 cm² from Baseline for participants with VAT≥100 cm² at Baseline.

Time frame: Week 72

Change From Baseline in Waist Circumference

Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with = Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Change From Baseline in Hemoglobin A1c (HbA1c)

Change from Baseline in HbA1c was assessed only for Participants with IGT at Baseline. LS mean was determined using MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Change From Baseline in Fasting Insulin for Participants With IGT at Baseline

Change from Baseline in Fasting Insulin for Participants with IGT at Baseline. LS mean was determined using MMRM model log(Baseline) + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Change From Baseline in Systolic Blood Pressure

Change from Baseline in Systolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Change From Baseline in Diastolic Blood Pressure

Change from Baseline in Diastolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score

The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score

The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.

Time frame: Baseline, Week 72

Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)

The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, unable to perform/extreme problems). In addition to the health profile, a single health state index value can be derived based on a formula that attaches weights to each of the levels in each dimension. This index value ranges between ˂0 (where 0 is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.

Time frame: Baseline, Week 72