Semaglutide for Obesity

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Obesity+3 More
Semaglutide - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new diabetes medication that is given once a week. It is for people who have not been able to control their diabetes well with other treatments.

Eligible Conditions
  • Obesity
  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Study Objectives

2 Primary · 18 Secondary · Reporting Duration: 26 weeks

26 weeks
Change in BMI (Kg/m2)
Change in CGM measured glycemic variability (coefficient of variation)
Change in HbA1c
Change in albumin to creatinine ratio (ACR)
Change in blood pressure (systolic, diastolic, mean and pulse pressure)
Change in brachial arterial distensibility (Brach D), augmentation index by radial artery tonometry [pulse wave analysis [PWA]), pulse wave velocity (PWV)], and carotid atherosclerosis by carotid intima media thickness (cIMT)
Change in cardiac and aortic structure and function measured by cardiac magnetic resonance (CMR)
Change in ectopic fat volumes in the abdomen and around the heart
Change in estimated glomerular filtration rate (eGFR)
Change in insulin dose (total daily dose, units/kg of body weight)
Change in lipid parameters
Change in mean glucose
Change in patient reported quality of life
Change in weight
Differences in CGM metrics (mean glucose, TIR, TAR, TBR and CV) by daytime vs nighttime
Percent time spent in CGM-measured glucose >180 mg/dL and >250 mg/dL
Percent time spent in CGM-measured glucose range of 70-140 mg/dL (time in tight target range; TTIR)
Percentage of patients achieving HbA1c <7%
Percentage of patients achieving TIR >70%
Proportion of adults with T1D achieving composite outcome (CGM-measured time in range (TIR)>70% with time below range (TBR) of <4% and reduction in body weight by 5%) at 26 weeks in the semaglutide group compared to placebo group
Proportion of adults with T1D achieving composite outcome (CGM-measured time in range (TIR)>70% with time below range (TBR) of <5% and reduction in body weight by 5%) at 26 weeks in the semaglutide group compared to placebo group
Severe hypoglycemia and diabetic ketoacidosis episodes

Trial Safety

Side Effects for

Overall Study
21%Nausea
12%Decreased Appetite
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04189848) in the Overall Study ARM group. Side effects include: Nausea with 21%, Decreased Appetite with 12%.

Trial Design

2 Treatment Groups

Semaglutide
1 of 2
Control
1 of 2
Experimental Treatment
Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: Semaglutide · Has Placebo Group · Phase 2

Semaglutide
Drug
Experimental Group · 1 Intervention: Semaglutide · Intervention Types: Drug
Control
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5560

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 26 weeks

Who is running the clinical trial?

Juvenile Diabetes Research FoundationOTHER
201 Previous Clinical Trials
55,462 Total Patients Enrolled
1 Trials studying Obesity
174 Patients Enrolled for Obesity
University of Colorado, DenverLead Sponsor
1,568 Previous Clinical Trials
1,923,329 Total Patients Enrolled
94 Trials studying Obesity
120,048 Patients Enrolled for Obesity
Viral N Shah, MDPrincipal InvestigatorUniversity of Colorado/Barbara Davis Center
Viral Shah, MDPrincipal InvestigatorUniversity of Colorado/Barbara Davis Center
3 Previous Clinical Trials
222 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been diagnosed with type 1 diabetes for at least 12 months.
You are on a FDA-approved hybrid closed-loop system (HCL) for ≥ 3 months.
You have a point-of-care HbA1c level of >7.0% and <10.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: October 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Washington100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%