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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

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.

Eligibility Criteria

Inclusion Criteria

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

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

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.

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
Glucagon-like peptide-1 (GLP-1) receptor agonists, such as Orforglipron, work by mimicking the incretin hormone GLP-1, which is released after eating. These medications enhance insulin secretion, inhibit glucagon release, slow gastric emptying, and promote satiety, leading to reduced food intake and weight loss. This mechanism is particularly beneficial for obesity patients as it addresses both hyperglycemia and excess weight, improving overall metabolic health and reducing cardiovascular risk. Other common treatments for obesity include lifestyle modifications, pharmacotherapy with medications like phentermine-topiramate, and bariatric surgery, each targeting different aspects of weight management and metabolic improvement.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,215,490 Total Patients Enrolled
57 Trials studying Obesity
49,205 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
413,856 Total Patients Enrolled
40 Trials studying Obesity
28,924 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
~749 spots leftby Jan 2025