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Orforglipron for Obesity

Biopharma Informatic, LLC, McAllen, TX
Obesity+6 More ConditionsOrforglipron - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test a new drug for type 2 diabetes with obesity and high cardiovascular risk, over 2 years with up to 27 visits.

Eligible Conditions
  • Obesity
  • Overweight or Obesity
  • Cardiovascular Disease
  • Type 2 Diabetes
  • Chronic Kidney Disease

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
LY3857210
1
Tirzepatide
1
CSL300 (Phase 3)

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline to End of the Study (Approximately 104 Weeks)

Baseline through Week 52
Pharmacokinetics (PK): Plasma Serum Concentrations of Orforglipron
Week 104
Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]
Week 104
Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death)
Baseline, Week 52
Change from Baseline in Body Weight
Change from Baseline in Daily Average 7-point Self-monitoring Blood Glucose (SMBG) Profile
Change from Baseline in Fasting Serum Glucose
Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Score
Week 52
Percent Change from Baseline Body Weight
Percentage of Participants with HbA1c Target Values Less Than (<)7.0% (53 mmol/mol)

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
LY3857210
1
Tirzepatide
2
CSL300 (Phase 3)

Side Effects for

Basal Bolus In-hospital
3%Surgical Reintervention
3%Renal
2%Infections
2%Hematologic
2%Gastrointestinal
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT02004366) in the Basal Bolus In-hospital ARM group. Side effects include: Surgical Reintervention with 3%, Renal with 3%, Infections with 2%, Hematologic with 2%, Gastrointestinal with 2%.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Insulin Glargine
1 of 2
Orforglipron
1 of 2

Active Control

Experimental Treatment

2620 Total Participants · 2 Treatment Groups

Primary Treatment: Orforglipron · No Placebo Group · Phase 3

Orforglipron
Drug
Experimental Group · 1 Intervention: Orforglipron · Intervention Types: Drug
Insulin Glargine
Drug
ActiveComparator Group · 1 Intervention: Insulin Glargine · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to end of the study (approximately 104 weeks)

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,497 Previous Clinical Trials
3,150,905 Total Patients Enrolled
31 Trials studying Obesity
29,404 Patients Enrolled for Obesity
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,278 Previous Clinical Trials
377,355 Total Patients Enrolled
21 Trials studying Obesity
12,659 Patients Enrolled for Obesity

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Missouri60.0%
Illinois10.9%
New Jersey5.5%
Other23.6%
What site did they apply to?
Clinical Research Professionals18.4%
Diabetes and Endocrinology Specialists20.4%
StudyMetrix Research28.6%
Other32.7%
What portion of applicants met pre-screening criteria?
Met criteria92.5%
Did not meet criteria7.5%
How many prior treatments have patients received?
047.1%
123.5%
29.8%
3+19.6%
Why did patients apply to this trial?
  • "Need help with weight loss"
  • "Also am pre diabetic and haveCKD"
  • "self preservation and quality of life"
  • "I need to lose weight and keep it off."
  • "I’ve just not had luck in losing weight."
What questions have other patients asked about this trial?
  • "What do I need to do?"
  • "How long do screning visits last?"
  • "How long do screening visits take?"
  • "What are the hours for screening appointments?"
  • "What are the adverse effects? When does it start?"

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Clinical Research Professionals: < 24 hours
Typically responds via
Email100.0%
References

Frequently Asked Questions

Is this experiment currently recruiting new participants?

"Affirmative. According to the clinicaltrials.gov platform, this medical trial is still recruiting patients; it was originally posted on April 3rd 2023 and had its most recent update on April 7th of that same year. It currently has 2620 participants from 319 different sites involved with the study." - Anonymous Online Contributor

Unverified Answer

How many locations are engaging in this research endeavor?

"Patients may join the trial at Cahaba Research - Pelham in Pelham, Arizona, Syed Research Consultants Llc in Sheffield, Arkansas and Aventiv Research in Mesa, California as well as an additional 319 sites." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned Orforglipron for use in clinical practice?

"After considering the Phase 3 trial data, our team at Power has judged Orforglipron to be a secure option with a score of 3 out of 3." - Anonymous Online Contributor

Unverified Answer

What is the total participant count for this research project?

"The sponsor of the research, Eli Lilly and Company, requires a total of 2620 patients to fulfill their clinical trial's inclusion criteria. This can be done by conducting trials out of Cahaba Research- Pelham in Pelham, Arizona and Syed Research Consultants Llc in Sheffield, Arkansas." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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