Clinical trial NCT05051579: A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Overweight and Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-09-21
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline in Body Weight in LY3502970 and Placebo
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Percent Change From Baseline in Body Weight in LY3502970 and Placebo
timeFrame: Baseline, Week 36
measure: Change From Baseline in Body Weight in LY3502970 and Placebo
timeFrame: Baseline, Week 26
measure: Change From Baseline in Body Weight in LY3502970 and Placebo
timeFrame: Baseline, Week 36
measure: Change From Baseline in Waist Circumference in LY3502970 and Placebo
timeFrame: Baseline, Week 26
measure: Change From Baseline in Waist Circumference in LY3502970 and Placebo
timeFrame: Baseline, Week 36
measure: Change From Baseline in BMI in LY3502970 and Placebo
timeFrame: Baseline, Week 26
measure: Change From Baseline in BMI in LY3502970 and Placebo
timeFrame: Baseline, Week 36
measure: Percentage of Participants With >=5% Body Weight Loss
timeFrame: Week 26
measure: Percentage of Participants With >=10% Body Weight Loss
timeFrame: Week 26
measure: Percentage of Participants With >=5% Body Weight Loss
timeFrame: Week 36
measure: Percentage of Participants With >=10% Body Weight Loss
timeFrame: Week 36
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Concord
country: United States
facility: John Muir Physician Network Research Center
state: California
city: Greenbrae
country: United States
facility: NorCal Medical Research, Inc
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: San Ramon
country: United States
facility: Norcal Endocrinology & Internal Medicine
state: California
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
city: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Center of Fort Worth
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Richmond
country: United States
facility: National Clinical Research, Inc
state: Virginia
city: Green Bay
country: United States
facility: St. Vincent Hospital d/b/a Prevea Health
state: Wisconsin
city: Calgary
country: Canada
facility: C-health Research
state: Alberta
city: Hamilton
country: Canada
facility: Wharton Medical Clinic
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Saint Marc des Carrières
country: Canada
facility: Centre Médical et Professionnel de l'Ouest de Portneuf
state: Quebec
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique
city: Kalocsa
country: Hungary
facility: Studium Egeszseghaz Kft
state: Bács-Kiskun
city: Gyongyos
country: Hungary
facility: Bugát Pál Kórház
state: Heves
city: Balatonfüred
country: Hungary
facility: DRC Gyógyszervizsgáló Központ
state: Veszprém
city: Nagykanizsa
country: Hungary
facility: Kanizsai Dorottya Korhaz
state: Zala
city: Budapest
country: Hungary
facility: Szent Margit Rendelőintézet Nonprofit Kft
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Budapest
country: Hungary
facility: TRANTOR'99 Bt. Anyagcsere Centrum
city: Budapest
country: Hungary
facility: Strazsahegy Medicina Bt.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Ponce
country: Puerto Rico
facility: Puerto Rico Medical Research
city: Ponce
country: Puerto Rico
facility: Research and Cardiovascular Corp.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-5615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: