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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05051579
Collaborator
(none)
270
Enrollment
36
Locations
5
Arms
12
Anticipated Duration (Months)
7.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 29, 2021
Anticipated Primary Completion Date :
Sep 29, 2022
Anticipated Study Completion Date :
Sep 29, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: LY3502970 Dose 1

Participants will receive LY3502970 administered orally

Drug: LY3502970
Administered orally

Experimental: LY3502970 Dose 2

Participants will receive LY3502970 administered orally

Drug: LY3502970
Administered orally

Experimental: LY3502970 Dose 3

Participants will receive LY3502970 administered orally

Drug: LY3502970
Administered orally

Experimental: LY3502970 Dose 4

Participants will receive LY3502970 administered orally

Drug: LY3502970
Administered orally

Placebo Comparator: Placebo

Placebo administered orally

Drug: Placebo
Administered orally

Outcome Measures

Primary Outcome Measures

  1. Percent Change From Baseline in Body Weight [Baseline, Week 26]

    Percent Change From Baseline in Body Weight

Secondary Outcome Measures

  1. Percent Change From Baseline in Body Weight [Baseline, Week 36]

    Percent Change From Baseline in Body Weight

  2. Change From Baseline in Body Weight [Baseline, Week 26]

    Change From Baseline in Body Weight

  3. Change From Baseline in Body Weight [Baseline, Week 36]

    Change From Baseline in Body Weight

  4. Percentage of Participants Who Achieve ≥5% in Body Weight [Week 26]

    Percentage of Participants Who Achieve ≥5% in Body Weight

  5. Percentage of Participants Who Achieve ≥5% in Body Weight [Week 36]

    Percentage of Participants Who Achieve ≥5% in Body Weight

  6. Percentage of Participants Who Achieve ≥10% in Body Weight [Week 26]

    Percentage of Participants Who Achieve ≥10% in Body Weight

  7. Percentage of Participants Who Achieve ≥10% in Body Weight [Week 36]

    Percentage of Participants Who Achieve ≥10% in Body Weight

  8. Percent Change From Baseline in Body Mass Index (BMI) [Baseline, Week 26]

    Percent Change From Baseline in BMI

  9. Percent Change From Baseline in BMI [Baseline, Week 36]

    Percent Change From Baseline in BMI

  10. Change From Baseline in Waist Circumference [Baseline, Week 26]

    Change From Baseline in Waist Circumference

  11. Change From Baseline in Waist Circumference [Baseline, Week 36]

    Change From Baseline in Waist Circumference

  12. Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 [Baseline to Week 36]

    PK: Steady State AUC of LY3502970

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Anaheim Clinical Trials, LLCAnaheimCaliforniaUnited States92801
2John Muir Physician Network Research CenterConcordCaliforniaUnited States94520
3Marin Endocrine Care & Research, Inc.GreenbraeCaliforniaUnited States94904
4UCSD - Altman Clinical and Translational Research Institute (ACTRI)La JollaCaliforniaUnited States92037
5Valley Clinical Trials, Inc.NorthridgeCaliforniaUnited States91325
6Norcal Endocrinology & Internal MedicineSan RamonCaliforniaUnited States94583
7Elite Clinical TrialsBlackfootIdahoUnited States83221
8Rocky Mountain Clinical ResearchIdaho FallsIdahoUnited States83404
9StudyMetrix ResearchSaint PetersMissouriUnited States63303
10Premier ResearchTrentonNew JerseyUnited States08611
11Lillestol ResearchFargoNorth DakotaUnited States58104
12Intend Research, LLCNormanOklahomaUnited States73069
13Capital Area Research, LLCCamp HillPennsylvaniaUnited States17011
14Preferred Primary Care Physicians, Preferred Clinical Research-St. ClairPittsburghPennsylvaniaUnited States15243
15Dallas Diabetes Research CenterDallasTexasUnited States75230
16Diabetes and Thyroid Center of Fort WorthFort WorthTexasUnited States76132
17Texas Diabetes & Endocrinology, P.A.Round RockTexasUnited States78681
18National Clinical Research, IncRichmondVirginiaUnited States23294
19St. Vincent Hospital d/b/a Prevea HealthGreen BayWisconsinUnited States54303
20C-health ResearchCalgaryAlbertaCanadaT2V 4J2
21Wharton Medical ClinicHamiltonOntarioCanadaL8L 5G8
22Bluewater Clinical Research Group Inc.SarniaOntarioCanadaN7T 4X3
23Centre Médical et Professionnel de l'Ouest de PortneufSaint Marc des CarrièresQuebecCanadaG0A 4B0
24Alpha Recherche CliniqueQuebecCanadaG2J 0C4
25ALPHA Recherche CliniqueQuebecCanadaG3K 2P8
26Studium Egeszseghaz KftKalocsaBacs-KiskunHungary6300
27Bugát Pál KórházGyöngyösHevesHungary3200
28DRC Gyógyszervizsgáló KözpontBalatonfüredVeszprémHungary8230
29Kanizsai Dorottya KorhazNagykanizsaZalaHungary8800
30Szent Margit Rendelőintézet Nonprofit KftBudapestHungary1032
31Clinexpert Kft.BudapestHungary1033
32TRANTOR'99 Bt. Anyagcsere CentrumBudapestHungary1213
33Strazsahegy Medicina Bt.BudapestHungaryH1171
34Debreceni Egyetem Klinikai KozpontDebrecenHungary4032
35Puerto Rico Medical ResearchPoncePuerto Rico00717
36Research and Cardiovascular Corp.PoncePuerto Rico00717

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05051579
Other Study ID Numbers:
  • 18210
  • J2A-MC-GZGI
  • 2021-002805-88
First Posted:
Sep 21, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021