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Hormone Therapy

Orforglipron for Type 2 Diabetes and Obesity (ACHIEVE-4 Trial)

Verified 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 been diagnosed with type 2 diabetes mellitus (T2DM)
Are at least 18 years of age or legal age of consent in the jurisdiction in which the study is taking place, whichever is older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of the study (approximately 104 weeks)
Awards & highlights

ACHIEVE-4 Trial 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.

Who is the study for?
This trial is for adults with type 2 diabetes and obesity or overweight, who also have a higher risk of heart disease. Participants should not be on insulin therapy but may be taking other diabetes medications.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a daily oral medication called Orforglipron compared to Insulin Glargine, an injectable insulin, over about two years with up to 27 visits.See study design
What are the potential side effects?
Possible side effects from Orforglipron could include digestive issues, changes in blood sugar levels, fatigue, and allergic reactions. Insulin Glargine might cause low blood sugar, weight gain, injection site reactions, and swelling.

ACHIEVE-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ACHIEVE-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of the study (approximately 104 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of the study (approximately 104 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]
Secondary outcome measures
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
+6 more

Side effects data

From 2017 Phase 4 trial • 295 Patients • NCT02004366
3%
Surgical Reintervention
3%
Renal
2%
Gastrointestinal
2%
Hematologic
2%
Infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Basal Bolus In-hospital
Linagliptin+80%Glargine Dose on d/c
Linagliptin+50%Glargine Dose on d/c
Linagliptin In-hospital
Linagliptin on Discharge

ACHIEVE-4 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OrforglipronExperimental Treatment1 Intervention
Participants will receive escalated doses of orforglipron orally.
Group II: Insulin GlargineActive Control1 Intervention
Participants will receive insulin glargine subcutaneously (SC). Doses will be individualized and titrated according to a treat-to-target algorithm.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,618 Previous Clinical Trials
3,198,940 Total Patients Enrolled
54 Trials studying Obesity
38,568 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
403,134 Total Patients Enrolled
37 Trials studying Obesity
18,287 Patients Enrolled for Obesity

Media Library

Insulin Glargine (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05803421 — Phase 3
Obesity Research Study Groups: Orforglipron, Insulin Glargine
Obesity Clinical Trial 2023: Insulin Glargine Highlights & Side Effects. Trial Name: NCT05803421 — Phase 3
Insulin Glargine (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05803421 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT05803421 — 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 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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
Missouri
Other
What site did they apply to?
Velocity Clinical Research, Westlake
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Renstar Medical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0

What questions have other patients asked about this trial?

what is next step? What do I need to do? Are your trials safe ? How long does screening take?
PatientReceived 1 prior treatment
Is this a paid clinical trial?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I really need help. Looking to lower A1C. Love to do this trial. i want to feel better.
PatientReceived 1 prior treatment
I'm obese and need help.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Clinical Research Professionals: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk
2023. "A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05803421.
All > Montreal > Spokane
~1123 spots leftby Jan 2025
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