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.
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.
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- 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
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
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
Puerto Rico2 sites
Puerto Rico Medical Research
Ponce, 00717
Research and Cardiovascular Corp.
Ponce, 00717
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.
- Conditions
- Obesity, Overweight and Obesity
- 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 group | Role | What they receive |
|---|---|---|
| 12 milligram (mg) LY3502970 | Experimental | 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. Receives: Drug: LY3502970 |
| 24 mg LY3502970 | Experimental | 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. Receives: Drug: LY3502970 |
| 36 mg-1 LY3502970 | Experimental | 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. Receives: Drug: LY3502970 |
| 36 mg-2 LY3502970 | Experimental | 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. Receives: Drug: LY3502970 |
| 45 mg-1 LY3502970 | Experimental | 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. Receives: Drug: LY3502970 |
| 45 mg-2 LY3502970 | Experimental | 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. Receives: Drug: LY3502970 |
| Placebo | Placebo comparator | Participants 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.
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)
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
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
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
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
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
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
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
Percentage of Participants With >=5% Body Weight Loss
Percentage of participants with >=5% body weight loss was reported.
Measured: Week 26
Percentage of Participants With >=10% Body Weight Loss
Percentage of participants with >=10% body weight loss was reported.
Measured: Week 26
Percentage of Participants With >=5% Body Weight Loss
Percentage of participants with >=5% body weight loss was reported.
Measured: Week 36
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.
- First posted21 Sep 2021
- Study start29 Sep 2021
- Primary completion25 Aug 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 40481478Wharton 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05051579
- Acronym / sponsor ID
- 18210
- Conditions
- Obesity, Overweight and Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 12 milligram (mg) LY3502970 | Experimental | Drug: LY3502970Participants 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. |
| 24 mg LY3502970 | Experimental | Drug: LY3502970Participants 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. |
| 36 mg-1 LY3502970 | Experimental | Drug: LY3502970Participants 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. |
| 36 mg-2 LY3502970 | Experimental | Drug: LY3502970Participants 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. |
| 45 mg-1 LY3502970 | Experimental | Drug: LY3502970Participants 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. |
| 45 mg-2 LY3502970 | Experimental | Drug: LY3502970Participants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo administered orally once daily until 36 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3502970Administered orally | Drug | 12 milligram (mg) LY3502970, 24 mg LY3502970, 36 mg-1 LY3502970, 36 mg-2 LY3502970, 45 mg-1 LY3502970, 45 mg-2 LY3502970 |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
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.
11 secondary outcomes
Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Time frame: Baseline, Week 36
Change From Baseline in Body Weight in LY3502970 and Placebo
Time frame: Baseline, Week 26
Change From Baseline in Body Weight in LY3502970 and Placebo
Time frame: Baseline, Week 36
Change From Baseline in Waist Circumference in LY3502970 and Placebo
Time frame: Baseline, Week 26
Change From Baseline in Waist Circumference in LY3502970 and Placebo
Time frame: Baseline, Week 36
Change From Baseline in BMI in LY3502970 and Placebo
Time frame: Baseline, Week 26
Change From Baseline in BMI in LY3502970 and Placebo
Time frame: Baseline, Week 36
Percentage of Participants With >=5% Body Weight Loss
Time frame: Week 26
Percentage of Participants With >=10% Body Weight Loss
Time frame: Week 26
Percentage of Participants With >=5% Body Weight Loss
Time frame: Week 36
Percentage of Participants With >=10% Body Weight Loss
Time frame: Week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40481478Wharton 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.
- Derived from this study: PubMed 37351564Wharton 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.
- A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related ComorbiditiesLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
35 sites in 4 countries: see every site and its status.
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.