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

August 23, 2023 updated by: Eli Lilly and Company

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
272

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G2J 0C4
        • ALPHA Recherche Clinique
      • Quebec, Canada, G3K 2P8
        • ALPHA Recherche Clinique
    • Alberta
      • Calgary, Alberta, Canada, T2V 4J2
        • C-health Research
    • Ontario
      • Hamilton, Ontario, Canada, L8L 5G8
        • Wharton Medical Clinic
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research Group Inc.
    • Quebec
      • Saint Marc des Carrières, Quebec, Canada, G0A 4B0
        • Centre Médical et Professionnel de l'Ouest de Portneuf
  • Hungary
      • Budapest, Hungary, 1033
        • Clinexpert Kft.
      • Budapest, Hungary, 1032
        • Szent Margit Rendelőintézet Nonprofit Kft
      • Budapest, Hungary, 1213
        • TRANTOR'99 Bt. Anyagcsere Centrum
      • Budapest, Hungary, H1171
        • Strazsahegy Medicina Bt.
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
    • Bács-Kiskun
      • Kalocsa, Bács-Kiskun, Hungary, 6300
        • Studium Egeszseghaz Kft
    • Heves
      • Gyongyos, Heves, Hungary, 3200
        • Bugat Pal Korhaz
    • Veszprém
      • Balatonfüred, Veszprém, Hungary, 8230
        • DRC Gyógyszervizsgáló Központ
    • Zala
      • Nagykanizsa, Zala, Hungary, 8800
        • Kanizsai Dorottya Korhaz
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Puerto Rico Medical Research
      • Ponce, Puerto Rico, 00717
        • Research and Cardiovascular Corp.
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials, LLC
      • Concord, California, United States, 94520
        • John Muir Physician Network Research Center
      • Greenbrae, California, United States, 94904
        • NorCal Medical Research, Inc
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • San Ramon, California, United States, 94583
        • Norcal Endocrinology & Internal Medicine
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Clinical Research
    • Missouri
      • Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
    • New Jersey
      • Trenton, New Jersey, United States, 08611
        • Premier Research
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research, LLC
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Capital Area Research, LLC
      • Pittsburgh, Pennsylvania, United States, 15243
        • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center
      • Fort Worth, Texas, United States, 76132
        • Diabetes and Thyroid Center of Fort Worth
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocrinology, P.A.
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clinical Research, Inc
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54303
        • St. Vincent Hospital d/b/a Prevea Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 12 milligram (mg) 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.
Drug: LY3502970
Administered orally
Experimental: 24 mg 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.
Drug: LY3502970
Administered orally
Experimental: 36 mg-1 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.
Drug: LY3502970
Administered orally
Experimental: 36 mg-2 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.
Drug: LY3502970
Administered orally
Experimental: 45 mg-1 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.
Drug: LY3502970
Administered orally
Experimental: 45 mg-2 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.
Drug: LY3502970
Administered orally
Placebo Comparator: Placebo
Participants received placebo administered orally once daily until 36 weeks.
Drug: Placebo
Administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Time Frame: 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.
Baseline, Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Time Frame: 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.
Baseline, Week 36
Change From Baseline in Body Weight in LY3502970 and Placebo
Time Frame: Baseline, Week 26
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
Change From Baseline in Body Weight in LY3502970 and Placebo
Time Frame: 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.
Baseline, Week 36
Change From Baseline in Waist Circumference in LY3502970 and Placebo
Time Frame: Baseline, Week 26
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
Change From Baseline in Waist Circumference in LY3502970 and Placebo
Time Frame: 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.
Baseline, Week 36
Change From Baseline in BMI in LY3502970 and Placebo
Time Frame: Baseline, Week 26
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
Change From Baseline in BMI in LY3502970 and Placebo
Time Frame: 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.
Baseline, Week 36
Percentage of Participants With >=5% Body Weight Loss
Time Frame: Week 26
Percentage of participants with >=5% body weight loss was reported.
Week 26
Percentage of Participants With >=10% Body Weight Loss
Time Frame: Week 26
Percentage of participants with >=10% body weight loss was reported.
Week 26
Percentage of Participants With >=5% Body Weight Loss
Time Frame: Week 36
Percentage of participants with >=5% body weight loss was reported.
Week 36
Percentage of Participants With >=10% Body Weight Loss
Time Frame: Week 36
Percentage of participants with >=10% body weight loss was reported.
Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18210
  • J2A-MC-GZGI (Other Identifier: Eli Lilly and Company)
  • 2021-002805-88 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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