LY3502970 for Type 2 Diabetes

No longer recruiting at 58 trial locations

Overseen By There may be multiple sites in this clinical trial. 10877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must be taking: Metformin

Must not be taking: GI motility drugs

Disqualifiers: Type 1 diabetes, Pancreatitis, Hypertension, Heart conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3502970 for individuals with type 2 diabetes who haven't succeeded with just diet, exercise, or metformin, a common diabetes medication. Researchers aim to assess how well LY3502970 manages blood sugar levels and its safety compared to a placebo (a dummy treatment with no active drug) and another drug, Dulaglutide. Individuals managing type 2 diabetes with lifestyle changes or a stable dose of metformin, and who have a stable body weight, might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of new diabetes therapies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on a stable dose of metformin if they are using it. Hormone replacement therapy is allowed if it has been stable for 3 months before starting the trial.

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

Research has shown that LY3502970, also known as Orforglipron, is generally as safe as current injectable treatments for type 2 diabetes, with most patients tolerating it well. Studies have examined its safety when taken with food and over extended periods, and no major issues have emerged.

For Dulaglutide, another treatment under comparison, common side effects include nausea, diarrhea, and vomiting. These reactions are typical but usually manageable.

Both treatments have undergone testing in people, and their safety records suggest they are well-tolerated. Participants should still consult their healthcare provider about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LY3502970 because it offers a novel approach to managing Type 2 Diabetes Mellitus. Unlike many existing treatments that often focus on improving insulin sensitivity or secretion, LY3502970 is designed to work on the body's energy balance mechanisms. This treatment is taken orally once a day, potentially making it more convenient for patients compared to injectable options like insulin or GLP-1 receptor agonists such as Dulaglutide. The unique mechanism of LY3502970 could provide an alternative for patients who struggle with current therapies, offering hope for better blood sugar control with a different mode of action.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research shows that LY3502970, also known as orforglipron, may help manage type 2 diabetes. In this trial, participants will receive different dosages of LY3502970. Studies have found that people taking LY3502970 had better blood sugar control compared to those taking a placebo. Specifically, participants using this treatment saw significant drops in their HbA1c levels, an important measure of blood sugar control. Early research also indicates that LY3502970 can improve fasting glucose levels, suggesting it could effectively manage diabetes.

For comparison, another arm of this trial involves Dulaglutide, a medication already approved for diabetes, which reduces HbA1c by about 1.5% with its 1.5 mg dose. Both treatments have effectively lowered blood sugar levels in people with type 2 diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 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

Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.

You are not of childbearing potential (WNOCBP).

You have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin.

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 over 26 weeks

26 weeks

Multiple visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dulaglutide
• LY3502970
• Placebo

How Is the Trial Designed?

Group I: 45 mg LY3502970 - 2 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 QD.

Group II: 45 mg LY3502970 - 1 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 QD.

Group III: 36 mg LY3502970 - 2 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 QD.

Group IV: 36 mg LY3502970 - 1 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 QD.

Group V: 3 milligrams (mg) LY3502970 Experimental Treatment 1 Intervention

Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).

Group VI: 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 QD.

Group VII: 12 mg LY3502970 Experimental Treatment 1 Intervention

Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.

Group VIII: 1.5 mg Dulaglutide Active Control 1 Intervention

Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).

Group IX: Placebo Placebo Group 1 Intervention

Participants received matching placebo.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7896253/

Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus ... In conclusion, the AWARD-11 trial demonstrated glycemic and weight benefits for patients using 3- and 4.5-mg doses of dulaglutide once weekly, without ...

2. trulicity.lilly.com trulicity.lilly.com/hcp/efficacy-weight

Clinical Trials: Lowereing A1C, Weight Change & CV Data In a clinical study, the mean A1C reduction from baseline was 1.5% for the 1.5 mg dose (active control); 1.6% for the 3.0 mg dose; and 1.8% for the 4.5 mg dose.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4665063/

Trulicity (Dulaglutide): A New GLP-1 Receptor Agonist Once ... In 6 clinical studies that included a total of 3342 patients with type 2 diabetes, treatment with dulaglutide resulted in greater reductions from baseline in ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589936824000161

Comparative efficacy and safety of weekly dulaglutide ... Dulaglutide, particularly at higher doses, demonstrates superior efficacy in lowering hemoglobin A1C and reducing hypoglycemia risk compared to Icodec insulin.

5. e-dmj.org e-dmj.org/journal/view.php?number=2809

Safety and Effectiveness of Dulaglutide in the Treatment ... The most common AEs associated with dulaglutide were gastrointestinal disorders (11.80%) plus general disorders and administration site conditions (8.89%).

6. ehs.lilly.com ehs.lilly.com/Trulicity_US%20SDS.pdf

Trulicity™ (dulaglutide) - SDS US - Eli Lilly Avoid contact with eyes, skin, and clothing. Wash hands thoroughly after handling. See Section 8 of the SDS for Personal Protective Equipment.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/125469s036lbl.pdf

Trulicity - accessdata.fda.gov WARNING: RISK OF THYROID C-CELL TUMORS. See full prescribing information for complete boxed warning. • Dulaglutide causes thyroid C-cell tumors in rats.

8. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/t/trulicityinj.pdf

New Zealand Data sheet 1. Trulicity (dulaglutide 1.5 mg/0.5 ... The safety and effectiveness of TRULICITY have not been established in children and adolescents under 18 years of age. Use in Renal Impairment.

9. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/Dulaglutide

Dulaglutide - PubChem - NIH Precautions for safe handling: Avoid contact with eyes, skin, and clothing. Wash hands thoroughly after handling. Lilly; Safety Data Sheet for Trulicity, ...

10. trulicity.lilly.com trulicity.lilly.com/how-to-use/side-effects

Side Effects of Trulicity (dulaglutide) & How to Manage Them The most common adverse reactions experienced with Trulicity are nausea, diarrhea, vomiting, abdominal pain, decreased appetite, indigestion and fatigue.