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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
Pivotal Trial
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Hemoglobin A1c (HbA1c)
Secondary study objectives
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 more

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220
26%
Nasopharyngitis
9%
Constipation
7%
Influenza
5%
Diabetic retinopathy
5%
Nausea
4%
Gastrooesophageal reflux disease
3%
Back pain
3%
Upper respiratory tract inflammation
2%
Abdominal discomfort
2%
Vomiting
2%
Diarrhoea
1%
Cardiac ablation
1%
Herpes zoster
1%
Ischaemic cerebral infarction
1%
Acute myocardial infarction
1%
Appendicitis
1%
Large intestine polyp
1%
Peritonitis
1%
Sudden hearing loss
1%
Rectal adenocarcinoma
1%
Spinal operation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg
Dulaglutide 0.75 mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Orforglipron
2024
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,670 Previous Clinical Trials
3,227,193 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,385 Previous Clinical Trials
424,815 Total Patients Enrolled
~573 spots leftby Jul 2025
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