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

NCT ID: NCT05051579

Last Updated: 2023-09-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-29

Study Completion Date

2022-11-22

Brief Summary

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

Detailed Description

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Conditions

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Obesity Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally

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.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally

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.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally

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.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally

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.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally

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.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally

Placebo

Participants received placebo administered orally once daily until 36 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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LY3502970

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Eli Lilly and Company

Locations

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Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

John Muir Physician Network Research Center

Concord, California, United States

Site Status

NorCal Medical Research, Inc

Greenbrae, California, United States

Site Status

Valley Clinical Trials, Inc.

Northridge, California, United States

Site Status

Norcal Endocrinology & Internal Medicine

San Ramon, California, United States

Site Status

Elite Clinical Trials

Blackfoot, Idaho, United States

Site Status

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Site Status

StudyMetrix Research

City of Saint Peters, Missouri, United States

Site Status

Premier Research

Trenton, New Jersey, United States

Site Status

Lillestol Research

Fargo, North Dakota, United States

Site Status

Intend Research, LLC

Norman, Oklahoma, United States

Site Status

Capital Area Research, LLC

Camp Hill, Pennsylvania, United States

Site Status

Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair

Pittsburgh, Pennsylvania, United States

Site Status

Dallas Diabetes Research Center

Dallas, Texas, United States

Site Status

Diabetes and Thyroid Center of Fort Worth

Fort Worth, Texas, United States

Site Status

Texas Diabetes & Endocrinology, P.A.

Round Rock, Texas, United States

Site Status

National Clinical Research, Inc

Richmond, Virginia, United States

Site Status

St. Vincent Hospital d/b/a Prevea Health

Green Bay, Wisconsin, United States

Site Status

C-health Research

Calgary, Alberta, Canada

Site Status

Wharton Medical Clinic

Hamilton, Ontario, Canada

Site Status

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, Canada

Site Status

Centre Médical et Professionnel de l'Ouest de Portneuf

Saint-Marc-des-Carrieres, Quebec, Canada

Site Status

Alpha Recherche Clinique

Québec, , Canada

Site Status

ALPHA Recherche Clinique

Québec, , Canada

Site Status

Studium Egeszseghaz Kft

Kalocsa, Bács-Kiskun county, Hungary

Site Status

Bugát Pál Kórház

Gyöngyös, Heves County, Hungary

Site Status

DRC Gyógyszervizsgáló Központ

Balatonfüred, Veszprém megye, Hungary

Site Status

Kanizsai Dorottya Korhaz

Nagykanizsa, Zala County, Hungary

Site Status

Szent Margit Rendelőintézet Nonprofit Kft

Budapest, , Hungary

Site Status

Clinexpert Kft.

Budapest, , Hungary

Site Status

TRANTOR'99 Bt. Anyagcsere Centrum

Budapest, , Hungary

Site Status

Strazsahegy Medicina Bt.

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Site Status

Puerto Rico Medical Research

Ponce, , Puerto Rico

Site Status

Research and Cardiovascular Corp.

Ponce, , Puerto Rico

Site Status

Countries

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United States Canada Hungary Puerto Rico

References

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Wharton S, Rosenstock J, Konige M, Lin Y, Duffin K, Wilson J, Banerjee H, Pirro V, Kazda C, Mather K. Treatment with orforglipron, an oral glucagon like peptide-1 receptor agonist, is associated with improvements of CV risk biomarkers in participants with type 2 diabetes or obesity without diabetes. Cardiovasc Diabetol. 2025 Jun 6;24(1):240. doi: 10.1186/s12933-025-02781-x.

Reference Type DERIVED
PMID: 40481478 (View on PubMed)

Wharton S, Blevins T, Connery L, Rosenstock J, Raha S, Liu R, Ma X, Mather KJ, Haupt A, Robins D, Pratt E, Kazda C, Konig M; GZGI Investigators. Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. N Engl J Med. 2023 Sep 7;389(10):877-888. doi: 10.1056/NEJMoa2302392. Epub 2023 Jun 23.

Reference Type DERIVED
PMID: 37351564 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://trials.lillytrialguide.com/en-US/trial/1R7BP1Yw5t6roV3ZWFGzYQ

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

Other Identifiers

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J2A-MC-GZGI

Identifier Type: OTHER

Identifier Source: secondary_id

2021-002805-88

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18210

Identifier Type: -

Identifier Source: org_study_id

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