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Orforglipron for Type 2 Diabetes (ACHIEVE-1 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 40
Awards & highlights

ACHIEVE-1 Trial 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.

ACHIEVE-1 Trial Eligibility Criteria

Inclusion Criteria

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

ACHIEVE-1 Trial 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

ACHIEVE-1 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.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,216,079 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,225 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project accepting new participants?

"Based on the information located on clinicaltrials.gov, this trial is not actively searching for enrollees. This study was first posted in August 15th of 2023 and updated lastly in July 25th of 2023. Although it isn't seeking candidates at present, there are 1,443 other trials currently recruiting participants across the world."

Answered by AI

In what number of sites is this clinical trial being actively administered?

"Clinical trial sites include Epic Medical Research - Surprise in Surprise, Quality of Life Medical & Research Center in Tucson and Neighborhood Healthcare Institute of Health in Escondido, with 92 other medical centres taking part."

Answered by AI

Is Orforglipron Dose 1 a viable option in terms of security and safety?

"Our team at Power believes that Orforglipron Dose 1 is relatively safe, awarding it a score of 3. This rating was informed by the Phase 3 trial's efficacy data and multiple instances of safety testing results."

Answered by AI

Who else is applying?

What site did they apply to?
Neighborhood Healthcare Institute of Health
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Aventiv Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I would like to lower my a1c and be healthier. I have tried different med and diabetes is worse. I am hoping to get some good results with this.
PatientReceived 1 prior treatment
~286 spots leftby Apr 2025