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Glucagon-like peptide-1 receptor agonist

Semaglutide for Type 2 Diabetes

Phase 4
Recruiting
Led By Francis Kim, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women 40-65 years of age
Be older than 18 years old
Must not have
History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
History of pancreatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will study the effect of a diabetes medication, semaglutide, on blood flow and permeability in the brain of people with Type-2 diabetes.

Who is the study for?
This trial is for men and women aged 40-65 with type-2 diabetes for at least 3 years, HbA1C levels between 7%-10%, and on stable blood sugar control medications. Excluded are those needing high insulin doses, pregnant or breastfeeding women, individuals with uncontrolled hypertension, a history of pancreatitis or certain cardiovascular events, family history of specific carcinomas or syndromes, severe kidney issues, recent pioglitazone treatment, or contraindications to MRI.
What is being tested?
The study tests the effects of Semaglutide versus placebo on intracranial blood flow and brain-barrier permeability in people with type-2 diabetes. Participants will be randomly assigned to receive either Semaglutide via auto-injector or a placebo. The main outcome will be measured using magnetic resonance images taken at baseline and after one year.
What are the potential side effects?
Potential side effects may include allergic reactions to Semaglutide components; however specific side effects are not listed here. As this drug class has been associated with stroke reduction but also risks like pancreatitis in some cases, monitoring for various symptoms would be important.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I or my family have a history of Medullary Thyroid Cancer or MEN 2.
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I have had pancreatitis before.
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I cannot monitor my blood sugar levels at home.
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I have had a heart attack, stroke, or a mini-stroke.
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My kidney function is low, with an eGFR under 45.
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My LDL cholesterol is over 130 mg/dL or I haven't been on a consistent statin treatment recently.
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I use more than 100 units of insulin daily.
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I am currently taking a medication similar to the study drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intracranial blood flow (IBF)
bloodbrain barrier Ktrans
Secondary study objectives
Inflammatory markers

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Subjects randomized to semaglutide for 1 year.
Group II: PlaceboPlacebo Group1 Intervention
Subjects randomized to placebo for 1 year.

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SIndustry Sponsor
1,552 Previous Clinical Trials
2,445,010 Total Patients Enrolled
647 Trials studying Diabetes
757,138 Patients Enrolled for Diabetes
University of WashingtonLead Sponsor
1,815 Previous Clinical Trials
1,912,998 Total Patients Enrolled
10 Trials studying Diabetes
4,602 Patients Enrolled for Diabetes
Francis Kim, MDPrincipal InvestigatorUniversity of Washington
5 Previous Clinical Trials
3,117 Total Patients Enrolled

Media Library

Semaglutide Auto-Injector (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05780905 — Phase 4
Diabetes Research Study Groups: Active, Placebo
Diabetes Clinical Trial 2023: Semaglutide Auto-Injector Highlights & Side Effects. Trial Name: NCT05780905 — Phase 4
Semaglutide Auto-Injector (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05780905 — Phase 4
~31 spots leftby Mar 2026
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