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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 72
Awards & highlights
ATTAIN-2 Trial 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.
ATTAIN-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ATTAIN-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 72
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 72
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 moreATTAIN-2 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
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,199,558 Total Patients Enrolled
53 Trials studying Obesity
39,328 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
403,752 Total Patients Enrolled
36 Trials studying Obesity
19,047 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of pancreatitis.I have Type 2 Diabetes with an HbA1c level between 7% and 10%, and have been on a stable treatment for at least 90 days.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.I or a close family member have had medullary thyroid cancer or MEN2.You need to have a body mass index (BMI) of 27 or higher.I am currently getting or planning to get treatment for eye problems related to diabetes.You have a body mass index (BMI) of 27.0 or higher.It seems like the criterion provided is incomplete. Can you please provide more context or clarify the criterion so that I can accurately summarize it?You have tried to lose weight with a diet before, but it didn't work.You have tried to lose weight through dieting before but it didn't work.I have Type 1 Diabetes or a history of severe diabetic complications.I have lost or gained more than 11 pounds in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Orforglipron Dose 1
- Group 2: Orforglipron Dose 2
- Group 3: Placebo
- Group 4: Orforglipron Dose 3
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT05872620 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the US Food and Drug Administration authorized Orforglipron Dose 1 for general usage?
"The safety of Orforglipron Dose 1 has been evaluated as a 3 on our team's rating system, due to the abundance of data from Phase 3 trials that supports its efficacy and verifies its robust security."
Answered by AI
How many locations are presently trialing this research endeavor?
"Novak Clinical Research - Tucson, Yuma Clinical Trials in California and AMCR Institute in Florida are some of the many trial sites running this clinical experiment. 136 other locations have also been chosen to participate."
Answered by AI
Is this research endeavor welcoming new participants?
"Reports on the clinicaltrials.gov portal indicate that this trial is not actively recruiting any new participants at present, despite having been initially posted in June of 2023 and updated as recently as May 15th 2023. Fortunately, there are still 2545 other studies currently seeking patients to join their trials."
Answered by AI
Who else is applying?
What state do they live in?
California
Arizona
Tennessee
Other
What site did they apply to?
Catalina Research Institute, LLC
Balanced Life Health Care Solutions/SKYCRNG
Las Vegas Medical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
2
0
What questions have other patients asked about this trial?
How long is trial? Does this study pay? When do we get started? What are the disqualifying factors?
PatientReceived 1 prior treatment
How to obtain more info about this Clinical Trial?
PatientReceived no prior treatments
Why did patients apply to this trial?
Don’t wanna take pills. Wanting to get rid of diabetes and lose weight. Always looking for ways to improve my health and others!
PatientReceived no prior treatments
I tried to loss weight. Want have my dietabetic under control. I've tried dieting with no success and would like to lose weight.
PatientReceived no prior treatments
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