1576 Participants Needed

Orforglipron vs Semaglutide for Type 2 Diabetes

(ACHIEVE-3 Trial)

Recruiting at 159 trial locations
BF
JM
DV
Evelyne Davidson - Top Doctors
Valparaiso, Indiana • Velocity Clinical ...
Anjanette Tan, MD | Diabetes & Thyroid ...
Dr. Sumana Gangi, MD, FACE | Southern ...
Our Team | ERA Health Research | United ...
Overseen ByChad Crystal
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
Must be taking: Metformin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must continue taking metformin at a stable dose if you are already on it.

What data supports the effectiveness of the drug Orforglipron vs Semaglutide for Type 2 Diabetes?

Semaglutide, a drug similar to Orforglipron, has been shown to effectively lower blood sugar levels and promote weight loss in people with type 2 diabetes. It works by stimulating insulin release and has been proven effective in various clinical trials.12345

Is Orforglipron or Semaglutide safe for humans?

Both Orforglipron and Semaglutide have been evaluated for safety in clinical trials for type 2 diabetes. Orforglipron has undergone Phase 1b and Phase 2 studies, while Semaglutide has been tested in multiple Phase III trials, showing a good safety profile in patients with type 2 diabetes.12367

How does the drug Orforglipron differ from other treatments for type 2 diabetes?

Orforglipron is unique because it is an oral, non-peptide drug that activates the glucagon-like peptide-1 receptor, unlike many other treatments that require injection. This makes it more convenient for patients who prefer not to use injections.12367

Research Team

C1

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

Eligibility Criteria

This trial is for adults with Type 2 Diabetes who have been taking metformin consistently and haven't achieved desired blood sugar control. Participants should not have had any significant weight changes or started new diets or intense exercise programs recently. They can't join if they have Type 1 Diabetes, recent severe diabetes complications, certain cancers, high serum calcitonin levels, advanced heart failure, are undergoing treatment for diabetic eye disease, or have severely reduced kidney function.

Inclusion Criteria

I have been taking at least 1500 mg of metformin daily for the last 90 days.
Your long-term blood sugar level (HbA1c) is between 7.0% and 10.5%.
I have Type 2 Diabetes.
See 2 more

Exclusion Criteria

I am getting or planning to get treatment for eye problems related to diabetes.
I have been cancer-free or in remission for less than 5 years.
I have had a severe diabetic complication in the last 6 months.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either orforglipron or semaglutide orally to assess efficacy and safety

61 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Orforglipron
  • Semaglutide
Trial OverviewThe study compares the effectiveness and safety of a new medication called Orforglipron to an existing drug named Semaglutide in managing blood sugar levels over approximately 61 weeks in people whose Type 2 Diabetes isn't well-controlled by metformin alone.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Orforglipron Dose 2Experimental Treatment1 Intervention
Participants will receive orforglipron orally.
Group II: Orforglipron Dose 1Experimental Treatment1 Intervention
Participants will receive orforglipron orally.
Group III: Semaglutide Dose 1Active Control1 Intervention
Participants will receive semaglutide orally.
Group IV: Semaglutide Dose 2Active Control1 Intervention
Participants will receive semaglutide orally.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

Semaglutide, a GLP-1 receptor agonist with a long half-life, effectively promotes insulin secretion in a glucose-dependent manner, making it a valuable treatment for type 2 diabetes, approved for use worldwide and in Japan since 2018.
Oral semaglutide (Rybelsus®) is the first GLP-1 receptor agonist available in pill form, showing continuous benefits in glycemic control for patients with type 2 diabetes across various stages, as demonstrated in multiple global clinical trials.
[New drug for type 2 diabetes: introduction of oral Semaglutide (Rybelsus® tablets), an oral GLP-1 receptor agonist].Miyasaka, K.[2022]
Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.
It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.
[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)].Scheen, AJ.[2019]
Semaglutide, administered once weekly, demonstrated superior reductions in HbA1c levels compared to liraglutide, with significant differences noted at various dosages, indicating better long-term glycemic control.
In terms of weight reduction, semaglutide also showed greater efficacy than liraglutide at certain doses, suggesting it may be a more effective option for managing both blood sugar and weight in patients with diabetes.
Weekly Semaglutide vs. Liraglutide Efficacy Profile: A Network Meta-Analysis.Alsugair, HA., Alshugair, IF., Alharbi, TJ., et al.[2021]

References

[New drug for type 2 diabetes: introduction of oral Semaglutide (Rybelsus® tablets), an oral GLP-1 receptor agonist]. [2022]
[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]
Weekly Semaglutide vs. Liraglutide Efficacy Profile: A Network Meta-Analysis. [2021]
Semaglutide and Diabetic Retinopathy Risk in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. [2022]
Semaglutide: First Global Approval. [2019]
Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. [2023]
Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1b, multicentre, blinded, placebo-controlled, randomized, multiple-ascending-dose study in people with type 2 diabetes. [2023]