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GLP-1 Receptor Agonist
Orforglipron vs Semaglutide for Type 2 Diabetes (ACHIEVE-3 Trial)
Verified Trial
Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have Type 2 Diabetes
Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol), as determined by the central laboratory at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
ACHIEVE-3 Trial Summary
This trial will compare a new diabetes drug with semaglutide to see if it's safe and effective for people with Type 2 diabetes who take metformin. The trial will last 61 weeks.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While specific side effects aren't listed here, drugs like Orforglipron and Semaglutide typically may cause gastrointestinal issues (like nausea or diarrhea), potential risk of low blood sugar episodes (hypoglycemia), headaches, fatigue and possible allergic reactions.
ACHIEVE-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Type 2 Diabetes.
Select...
Your long-term blood sugar level (HbA1c) is between 7.0% and 10.5%.
Select...
I have been taking at least 1500 mg of metformin daily for the last 90 days.
ACHIEVE-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Hemoglobin A1c (HbA1c)
Secondary outcome measures
Change from Baseline in Body Weight
Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose (SMBG)
Change from Baseline in Diastolic Blood Pressure (DBP)
+17 moreSide effects data
From 2018 Phase 3 trial • 458 Patients • NCT0301522029%
Nasopharyngitis
9%
Constipation
9%
Nausea
8%
Upper respiratory tract inflammation
6%
Back pain
6%
Diarrhoea
5%
Decreased appetite
3%
Influenza
3%
Diabetic retinopathy
2%
Atrioventricular block second degree
2%
Abdominal discomfort
2%
Vomiting
2%
Angina pectoris
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dulaglutide 0.75 mg
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg
ACHIEVE-3 Trial Design
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 Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,215,023 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
414,169 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare facilities are administering this trial?
"Currently, 134 participants have enrolled in this clinical trial – these include the San Fernando Valley Health Institute of Canoga Park, Neighborhood Healthcare Institute of Escondido and Velocity Clinical Research Gardena. Additionally, there are other sites around the country."
Answered by AI
What potential adverse effects can be caused by administering Orforglipron Dose 1?
"Orforglipron Dose 1 has been proven safe in prior clinical studies, thus it was assigned a score of 3."
Answered by AI
Are there any remaining opportunities for individuals to partake in this research?
"The details posted on clinicaltrials.gov inform us that this study is not presently engaging in patient recruitment. It was initially featured on September 27th 2023 and last updated nine days later, but 1479 other trials are actively searching for candidates right now."
Answered by AI
Who else is applying?
What site did they apply to?
Infinity Clinical Research - Norco
Clinical Research of West Florida
Absolute Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I need the money. I was on ozempic then was. Want to improve my health. I am interested in weight loss.
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Clinical Research of West Florida: < 48 hours
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