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Orforglipron for Obesity (ATTAIN-2 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 a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of either diet/exercise alone or up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA)).
Be older than 18 years old
Must not have
Have had a history of chronic or acute pancreatitis.
Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 72
Awards & highlights

Summary

This trial will research a once-daily oral treatment for obesity/overweight and diabetes, with up to 22 visits over 77 weeks.

Who is the study for?
Adults with obesity or overweight and type 2 diabetes are eligible for this trial. They must have tried to lose weight through dieting without success, have stable blood sugar levels on up to three oral diabetes medications (excluding certain types), and a BMI of at least 27.0 kg/m². Those with recent significant weight changes, Type 1 Diabetes, diabetic eye treatment plans, or a history/family history of specific thyroid cancers cannot participate.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of Orforglipron, an oral medication taken once daily for reducing body weight in adults with obesity/overweight and type 2 diabetes. Participants will be randomly assigned to receive either Orforglipron or a placebo over approximately 77 weeks with up to 22 visits.See study design
What are the potential side effects?
While the specific side effects of Orforglipron are not listed here, common side effects from weight loss drugs can include digestive issues like nausea or constipation, headaches, dry mouth, fatigue and sometimes more serious reactions depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Type 2 Diabetes with an HbA1c level between 7% and 10%, and have been on a stable treatment plan for at least 90 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of pancreatitis.
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I or a close family member have had medullary thyroid cancer or MEN2.
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I have Type 1 Diabetes or a history of severe diabetic complications.
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I have lost or gained more than 11 pounds in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 72 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Percent Change from Baseline in Body Weight
Secondary outcome measures
Mean Change from Baseline in Diastolic Blood Pressure (DBP)
Mean Change from Baseline in Fasting Glucose
Mean Change from Baseline in Fasting Triglycerides
+6 more

Trial Design

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

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, which is naturally released after meals. They enhance insulin secretion, inhibit glucagon release, slow gastric emptying, and increase feelings of fullness, leading to reduced food intake and weight loss. These mechanisms are significant for obesity patients as they help manage weight and improve metabolic health, thereby reducing the risk of obesity-related complications like type 2 diabetes and cardiovascular diseases.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,216,610 Total Patients Enrolled
57 Trials studying Obesity
50,325 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
414,976 Total Patients Enrolled
40 Trials studying Obesity
30,044 Patients Enrolled for Obesity

Media Library

Orforglipron (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05872620 — Phase 3
Obesity Research Study Groups: Orforglipron Dose 1, Orforglipron Dose 2, Placebo, Orforglipron Dose 3
Obesity Clinical Trial 2023: Orforglipron Highlights & Side Effects. Trial Name: NCT05872620 — Phase 3
Orforglipron (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05872620 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT05872620 — Phase 3
~652 spots leftby Jun 2025