LY3502970 for Obesity

No longer recruiting at 42 trial locations

Overseen By There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Diabetes, Obesity surgery, Renal impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3502970 to evaluate its effectiveness for individuals who are overweight or have obesity. The researchers aim to determine if the drug can manage weight and improve related health issues, such as high blood pressure or heart problems. Participants will receive varying doses of the drug or a placebo for comparison. This trial suits those with a BMI of 30 or higher, or a BMI of 27-29.9 with weight-related conditions like high blood pressure, who have maintained a stable weight over the past three months. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a stable condition like Major Depressive Disorder or generalized anxiety disorder, you may be included if you are not on excluded medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LY3502970, also known as Orforglipron, appears safe for humans. Its safety profile is similar to that of well-known injected diabetes medicines called GLP-1 receptor agonists, indicating it is generally well-tolerated.

Testing in people revealed side effects similar to those of other similar drugs, supporting further research. Current studies focus on its long-term safety, particularly for individuals with type 2 diabetes. Although still under study, these early results are promising for treating obesity and related conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about LY3502970 for obesity and overweight conditions because it offers a novel approach compared to existing treatments like lifestyle changes, medications such as orlistat, and GLP-1 receptor agonists like semaglutide. Unlike these options, LY3502970 is designed to be taken orally and works by targeting a different mechanism in the body, potentially providing a new pathway for weight loss. This could lead to more effective and sustained weight loss for individuals struggling with obesity-related health issues. Additionally, the treatment involves a dose-escalation method, which might help in minimizing side effects while optimizing results.

What evidence suggests that this trial's treatments could be effective for obesity or overweight?

Research has shown that LY3502970, also known as orforglipron, may help reduce body weight. Studies have found that this treatment can lower blood sugar levels, which is important for managing weight. LY3502970 activates the GLP-1 receptor, helping to control appetite and blood sugar. Early results suggest this activation helps people feel full faster, aiding in weight loss. Additionally, better blood sugar control has been observed, which may also assist with weight loss. These findings are promising, but more research is needed to fully understand the benefits for individuals who are overweight or have obesity. Participants in this trial will receive different dosages of LY3502970 or a placebo to further evaluate its effectiveness and safety. ^{4 6 7 8 9}

Who Is on the Research Team?

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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3502970 or placebo with dose escalation until a maintenance dose is reached, administered orally once daily for 36 weeks

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3502970
• Placebo

How Is the Trial Designed?

Group I: 45 mg-2 LY3502970 Experimental Treatment 1 Intervention

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 II: 45 mg-1 LY3502970 Experimental Treatment 1 Intervention

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 III: 36 mg-2 LY3502970 Experimental Treatment 1 Intervention

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 IV: 36 mg-1 LY3502970 Experimental Treatment 1 Intervention

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 V: 24 mg LY3502970 Experimental Treatment 1 Intervention

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 VI: 12 milligram (mg) LY3502970 Experimental Treatment 1 Intervention

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 VII: Placebo Placebo Group 1 Intervention

Participants received placebo administered orally once daily until 36 weeks.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2511774

Orforglipron, an Oral Small-Molecule GLP-1 Receptor ... The efficacy estimand represents the treatment effect as if all the randomized patients adhered to the administration of either orforglipron or ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37264711/

Orforglipron (LY3502970), a novel, oral non-peptide ... Results: A total of 51 participants received orforglipron and 17 received placebo. In the placebo and orforglipron groups, respectively, baseline HbA1c was 8.1% ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05803421

NCT05803421 | A Study of Daily Oral Orforglipron ( ... The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15184

Orforglipron (LY3502970), a novel, oral non‐peptide glucagon ... PD results showed significant improvements in plasma glucose during fasting and following an OGTT for some orforglipron doses compared with ...

5. pnas.org pnas.org/doi/10.1073/pnas.2014879117

Structural basis for GLP-1 receptor activation by ... - PNAS In efficacy studies, oral administration of LY3502970 resulted in glucose lowering in humanized GLP-1R transgenic mice and insulinotropic and ...

6. abmole.com abmole.com/literature/ly3502970-msds.html?srsltid=AfmBOopD9sI5oIEcX372bgY1MPI4UygAuS032MvAeql13w-6QobdO7zT

Material Safety Data Sheet of LY3502970 Material Safety Data Sheet of LY3502970 contains identification of substance and details of the supplier of the safety data sheet.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37344954/

Orforglipron (LY3502970), a novel, oral non-peptide ... Orforglipron had a pharmacodynamic and safety profile similar to that of injectable GLP-1RAs, which supports continued clinical development.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06010004

NCT06010004 | A Long-term Safety Study of Orforglipron ( ... A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes (ACHIEVE-J). ClinicalTrials.gov ID NCT06010004.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10951152/

Effect of Food Consumption on the Pharmacokinetics ... We assessed the effect of the prandial state on the pharmacokinetics, safety, and tolerability of single and multiple doses of orforglipron (LY3502970).