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Orforglipron for Type 2 Diabetes (ACHIEVE-1 Trial)

Phase 3
Waitlist Available
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
Be older than 18 years old
Must not have
Have New York Heart Association functional classification IV congestive heart failure.
Have acute or chronic pancreatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 40
Awards & highlights

Summary

This trial will study if a new diabetes drug is safe and helps control blood sugar levels in adults with type 2 diabetes. It will last 54 weeks.

Who is the study for?
Adults with Type 2 Diabetes who haven't been able to control their blood sugar levels through diet and exercise alone can join. They should have a stable weight, a BMI of at least 23, and an HbA1c level between 7.0% to 9.5%. Participants shouldn't be on insulin or other diabetes medications for the last 90 days.Check my eligibility
What is being tested?
The trial is testing Orforglipron against a placebo in adults with Type 2 Diabetes over approximately one year. The goal is to see if Orforglipron is safe and more effective than no treatment (placebo) in controlling blood sugar levels.See study design
What are the potential side effects?
Possible side effects of Orforglipron are not detailed here but may include typical drug reactions such as nausea, headache, dizziness, or allergic reactions. Side effects will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Type 2 Diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe heart failure.
Select...
I have pancreatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 40
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 40 for reporting.

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 Fasting Serum Glucose
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Orforglipron Dose 3Experimental Treatment1 Intervention
Participants will receive orforglipron orally.
Group II: Orforglipron Dose 2Experimental Treatment1 Intervention
Participants will receive orforglipron orally.
Group III: Orforglipron Dose 1Experimental Treatment1 Intervention
Participants will receive orforglipron orally.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo orally.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
GLP-1 receptor agonists, such as Orforglipron, mimic the incretin hormone GLP-1 to enhance insulin secretion, inhibit glucagon release, slow gastric emptying, and promote satiety, leading to improved glycemic control and potential weight loss. This multifaceted approach is crucial for Type 2 Diabetes patients as it addresses several underlying issues of the disease. Other common treatments include metformin, which reduces hepatic glucose production and increases insulin sensitivity, and insulin therapy, which directly supplements insulin levels. These treatments collectively help manage blood glucose levels effectively.
Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,217,590 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
415,956 Total Patients Enrolled

Media Library

Forglipron (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05971940 — Phase 3
Type 2 Diabetes Research Study Groups: Orforglipron Dose 2, Orforglipron Dose 3, Orforglipron Dose 1, Placebo
Type 2 Diabetes Clinical Trial 2023: Forglipron Highlights & Side Effects. Trial Name: NCT05971940 — Phase 3
Forglipron (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05971940 — Phase 3
~208 spots leftby Apr 2025