A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities

Obesity Clinical Trial

Official title:

A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05051579
• Other study ID #: 18210
• Secondary ID: J2A-MC-GZGI2021-
• Status: Completed
• Phase: Phase 2
• Start date: September 29, 2021
• Est. completion date: November 22, 2022

Study information

• Verified date: August 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: November 22, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Drug:
• LY3502970
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Canada	C-health Research	Calgary	Alberta
Canada	Wharton Medical Clinic	Hamilton	Ontario
Canada	Alpha Recherche Clinique	Quebec
Canada	ALPHA Recherche Clinique	Quebec
Canada	Centre Médical et Professionnel de l'Ouest de Portneuf	Saint Marc des Carrières	Quebec
Canada	Bluewater Clinical Research Group Inc.	Sarnia	Ontario
Hungary	DRC Gyógyszervizsgáló Központ	Balatonfüred	Veszprém
Hungary	Clinexpert Kft.	Budapest
Hungary	Strazsahegy Medicina Bt.	Budapest
Hungary	Szent Margit Rendelointézet Nonprofit Kft	Budapest
Hungary	TRANTOR'99 Bt. Anyagcsere Centrum	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Bugát Pál Kórház	Gyongyos	Heves
Hungary	Studium Egeszseghaz Kft	Kalocsa	Bács-Kiskun
Hungary	Kanizsai Dorottya Korhaz	Nagykanizsa	Zala
Puerto Rico	Puerto Rico Medical Research	Ponce
Puerto Rico	Research and Cardiovascular Corp.	Ponce
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Elite Clinical Trials	Blackfoot	Idaho
United States	Capital Area Research, LLC	Camp Hill	Pennsylvania
United States	John Muir Physician Network Research Center	Concord	California
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Lillestol Research	Fargo	North Dakota
United States	Diabetes and Thyroid Center of Fort Worth	Fort Worth	Texas
United States	St. Vincent Hospital d/b/a Prevea Health	Green Bay	Wisconsin
United States	NorCal Medical Research, Inc	Greenbrae	California
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Intend Research, LLC	Norman	Oklahoma
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair	Pittsburgh	Pennsylvania
United States	National Clinical Research, Inc	Richmond	Virginia
United States	Texas Diabetes & Endocrinology, P.A.	Round Rock	Texas
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Norcal Endocrinology & Internal Medicine	San Ramon	California
United States	Premier Research	Trenton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Body Weight in LY3502970 and Placebo	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.	Baseline, Week 26
Secondary	Percent Change From Baseline in Body Weight in LY3502970 and Placebo	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.	Baseline, Week 36
Secondary	Change From Baseline in Body Weight in LY3502970 and Placebo	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.	Baseline, Week 26
Secondary	Change From Baseline in Body Weight in LY3502970 and Placebo	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.	Baseline, Week 36
Secondary	Change From Baseline in Waist Circumference in LY3502970 and Placebo	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.	Baseline, Week 26
Secondary	Change From Baseline in Waist Circumference in LY3502970 and Placebo	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.	Baseline, Week 36
Secondary	Change From Baseline in BMI in LY3502970 and Placebo	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.	Baseline, Week 26
Secondary	Change From Baseline in BMI in LY3502970 and Placebo	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.	Baseline, Week 36
Secondary	Percentage of Participants With >=5% Body Weight Loss	Percentage of participants with >=5% body weight loss was reported.	Week 26
Secondary	Percentage of Participants With >=10% Body Weight Loss	Percentage of participants with >=10% body weight loss was reported.	Week 26
Secondary	Percentage of Participants With >=5% Body Weight Loss	Percentage of participants with >=5% body weight loss was reported.	Week 36
Secondary	Percentage of Participants With >=10% Body Weight Loss	Percentage of participants with >=10% body weight loss was reported.	Week 36

External Links

•   A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities