AzTrials
AzTrials

ObesityPhase 2NCT05051579

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

A Phase 2 study testing LY3502970 in people with Obesity and Overweight and Obesity, run by Eli Lilly and Company at 35 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity, Overweight and Obesity
What is being tested?
LY3502970
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
272 participants
Where
35 sitesin 4 countries
Study dates
29 Sep 2021to 22 Nov 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

35 sites in 4 countries.

35 sites in 4 countries

United States18 sites
  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • John Muir Physician Network Research Center

    Concord, California, 94520

  • Dallas Diabetes Research Center

    Dallas, Texas, 75230

  • Lillestol Research

    Fargo, North Dakota, 58104

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas, 76132

  • St. Vincent Hospital d/b/a Prevea Health

    Green Bay, Wisconsin, 54303

  • NorCal Medical Research, Inc

    Greenbrae, California, 94904

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Intend Research, LLC

    Norman, Oklahoma, 73069

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

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

    Pittsburgh, Pennsylvania, 15243

  • National Clinical Research, Inc

    Richmond, Virginia, 23294

  • Texas Diabetes & Endocrinology, P.A.

    Round Rock, Texas, 78681

  • Norcal Endocrinology & Internal Medicine

    San Ramon, California, 94583

  • Premier Research

    Trenton, New Jersey, 08611

Other trials in United States

Hungary9 sites
  • DRC Gyógyszervizsgáló Központ

    Balatonfüred, Veszprém megye, 8230

  • Szent Margit Rendelőintézet Nonprofit Kft

    Budapest, 1032

  • Clinexpert Kft.

    Budapest, 1033

  • TRANTOR'99 Bt. Anyagcsere Centrum

    Budapest, 1213

  • Strazsahegy Medicina Bt.

    Budapest, H1171

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Bugát Pál Kórház

    Gyöngyös, Heves County, 3200

  • Studium Egeszseghaz Kft

    Kalocsa, Bács-Kiskun county, 6300

  • Kanizsai Dorottya Korhaz

    Nagykanizsa, Zala County, 8800

Other trials in Hungary

Canada6 sites
  • C-health Research

    Calgary, Alberta, T2V 4J2

  • Wharton Medical Clinic

    Hamilton, Ontario, L8L 5G8

  • Alpha Recherche Clinique

    Québec, G2J 0C4

  • ALPHA Recherche Clinique

    Québec, G3K 2P8

  • Centre Médical et Professionnel de l'Ouest de Portneuf

    Saint-Marc-des-Carrieres, Quebec, G0A 4B0

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario, N7T 4X3

Other trials in Canada

Puerto Rico2 sites
  • Puerto Rico Medical Research

    Ponce, 00717

  • Research and Cardiovascular Corp.

    Ponce, 00717

Other trials in Puerto Rico

About this study

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

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

Being tested
LY3502970, Placebo
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3502970Drug

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT05051579
Study groupRoleWhat they receive
12 milligram (mg) LY3502970ExperimentalParticipants 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.
Receives: Drug: LY3502970
24 mg LY3502970ExperimentalParticipants 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.
Receives: Drug: LY3502970
36 mg-1 LY3502970ExperimentalParticipants 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.
Receives: Drug: LY3502970
36 mg-2 LY3502970ExperimentalParticipants 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.
Receives: Drug: LY3502970
45 mg-1 LY3502970ExperimentalParticipants 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.
Receives: Drug: LY3502970
45 mg-2 LY3502970ExperimentalParticipants 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.
Receives: Drug: LY3502970
PlaceboPlacebo comparatorParticipants received placebo administered orally once daily until 36 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 26

Secondary outcomes (11)
  1. 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.

    Measured: Baseline, Week 36

  2. 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.

    Measured: Baseline, Week 26

  3. 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.

    Measured: Baseline, Week 36

  4. 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.

    Measured: Baseline, Week 26

  5. 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.

    Measured: Baseline, Week 36

  6. 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.

    Measured: Baseline, Week 26

  7. 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.

    Measured: Baseline, Week 36

  8. Percentage of Participants With >=5% Body Weight Loss

    Percentage of participants with >=5% body weight loss was reported.

    Measured: Week 26

  9. Percentage of Participants With >=10% Body Weight Loss

    Percentage of participants with >=10% body weight loss was reported.

    Measured: Week 26

  10. Percentage of Participants With >=5% Body Weight Loss

    Percentage of participants with >=5% body weight loss was reported.

    Measured: Week 36

  11. Percentage of Participants With >=10% Body Weight Loss

    Percentage of participants with >=10% body weight loss was reported.

    Measured: Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2021
  2. Study start29 Sep 2021
  3. Primary completion25 Aug 2022
  4. Study completion22 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05051579
Sponsor's protocol ID
18210
Other IDs
J2A-MC-GZGI, 2021-002805-88
Status last verified
Aug 2023
First submitted
17 Sep 2021
Last updated
13 Sep 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 40481478
  • 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.

    PubMed 37351564

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3502970 in people with Obesity and Overweight and Obesity, run by Eli Lilly and Company at 35 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Hungary, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Body Weight in LY3502970 and Placebo (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05051579, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in