A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
- Conditions
- ObesityOverweight and Obesity
- Interventions
- Drug: LY3502970Drug: Placebo
- Registration Number
- NCT05051579
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 272
- Have a body mass index (BMI) of ≥30-kilogram square meter (kg/m²)
- Have a BMI ≥27 kg/m² and <30 kg/m² with at least 1 of the following weight-related comorbidities eg; [Have hypertension, or dyslipidemia, cardiovascular disease]
- Have had a stable body weight for the 3 months prior to randomization (not more than 5% body weight gain and/or loss)
- Have any prior diagnosis of diabetes
- Have a prior or planned surgical treatment for obesity
- Have obesity induced by other endocrinological disorders or diagnosed monogenetic or syndromic forms of obesity
- Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30 milliliter (mL)/minute (min)/1.73 m²
- Have a history of acute chronic pancreatitis
- Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years Note: Participants with MDD or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, may be considered for inclusion if they are not on excluded medications.
Within 3 months prior to screening:
- Have poorly controlled hypertension
- Have history of acute myocardial infarction
- Have history of cerebrovascular accident (stroke)
- Had hospitalization due to congestive heart failure (CHF)
- Have cancer
- Have human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening
- Have hepatitis B and/or positive hepatitis B surface antigen
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 12 milligram (mg) LY3502970 LY3502970 Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks. 24 mg LY3502970 LY3502970 Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks. 36 mg-1 LY3502970 LY3502970 Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks. 36 mg-2 LY3502970 LY3502970 Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks. 45 mg-1 LY3502970 LY3502970 Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks. 45 mg-2 LY3502970 LY3502970 Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks. Placebo Placebo Participants received placebo administered orally once daily until 36 weeks.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Body Weight in LY3502970 and Placebo Baseline, Week 26 Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With >=10% Body Weight Loss Week 36 Percentage of participants with \>=10% body weight loss was reported.
Change From Baseline in Body Weight in LY3502970 and Placebo Baseline, Week 36 LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Change From Baseline in Waist Circumference in LY3502970 and Placebo Baseline, Week 36 LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Change From Baseline in BMI in LY3502970 and Placebo Baseline, Week 36 LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Percentage of Participants With >=5% Body Weight Loss Week 36 Percentage of participants with \>=5% body weight loss was reported.
Percent Change From Baseline in Body Weight in LY3502970 and Placebo Baseline, Week 36 LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Trial Locations
- Locations (35)
DRC Gyógyszervizsgáló Központ
🇭🇺Balatonfüred, Veszprém, Hungary
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
NorCal Medical Research, Inc
🇺🇸Greenbrae, California, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
John Muir Physician Network Research Center
🇺🇸Concord, California, United States
Wharton Medical Clinic
🇨🇦Hamilton, Ontario, Canada
Alpha Recherche Clinique
🇨🇦Quebec, Canada
Norcal Endocrinology & Internal Medicine
🇺🇸San Ramon, California, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Elite Clinical Trials
🇺🇸Blackfoot, Idaho, United States
Intend Research, LLC
🇺🇸Norman, Oklahoma, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Premier Research
🇺🇸Trenton, New Jersey, United States
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
🇺🇸Pittsburgh, Pennsylvania, United States
Capital Area Research, LLC
🇺🇸Camp Hill, Pennsylvania, United States
Diabetes and Thyroid Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Round Rock, Texas, United States
St. Vincent Hospital d/b/a Prevea Health
🇺🇸Green Bay, Wisconsin, United States
C-health Research
🇨🇦Calgary, Alberta, Canada
ALPHA Recherche Clinique
🇨🇦Quebec, Canada
Bluewater Clinical Research Group Inc.
🇨🇦Sarnia, Ontario, Canada
Studium Egeszseghaz Kft
🇭🇺Kalocsa, Bács-Kiskun, Hungary
Centre Médical et Professionnel de l'Ouest de Portneuf
🇨🇦Saint Marc des Carrières, Quebec, Canada
Bugát Pál Kórház
🇭🇺Gyongyos, Heves, Hungary
Kanizsai Dorottya Korhaz
🇭🇺Nagykanizsa, Zala, Hungary
TRANTOR'99 Bt. Anyagcsere Centrum
🇭🇺Budapest, Hungary
Szent Margit Rendelőintézet Nonprofit Kft
🇭🇺Budapest, Hungary
Clinexpert Kft.
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Strazsahegy Medicina Bt.
🇭🇺Budapest, Hungary
Puerto Rico Medical Research
🇵🇷Ponce, Puerto Rico
Research and Cardiovascular Corp.
🇵🇷Ponce, Puerto Rico
National Clinical Research, Inc
🇺🇸Richmond, Virginia, United States