Semaglutide 7.2 mg for Type 2 Diabetes

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

Study Summary

This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years.

Eligible Conditions
  • Obesity
  • Type 2 Diabetes

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

2 Primary · 27 Secondary · Reporting Duration: From baseline (week 0) to end of study (week 81)

Week 81
Semaglutide 7.2 mg versus Placebo: Number of adverse events (AEs)
Semaglutide 7.2 mg versus Placebo: Number of serious adverse events (SAEs)
Semaglutide 7.2 mg versus Placebo: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of AEs
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
Week 72
Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI)
Semaglutide 7.2 mg versus Placebo: Change in body weight
Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure
Semaglutide 7.2 mg versus Placebo: Change in fasting plasma glucose
Semaglutide 7.2 mg versus Placebo: Change in fasting serum insulin
Semaglutide 7.2 mg versus Placebo: Change in free fatty acids
Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c)
Semaglutide 7.2 mg versus Placebo: Change in high-density lipoprotein (HDL) cholesterol
Semaglutide 7.2 mg versus Placebo: Change in high-sensitivity c reactive protein (hsCRP)
Semaglutide 7.2 mg versus Placebo: Change in low-density lipoprotein (LDL) cholesterol
Semaglutide 7.2 mg versus Placebo: Change in pulse
Semaglutide 7.2 mg versus Placebo: Change in systolic blood pressure
Semaglutide 7.2 mg versus Placebo: Change in total cholesterol
Semaglutide 7.2 mg versus Placebo: Change in triglycerides
Semaglutide 7.2 mg versus Placebo: Change in very-low-density lipoprotein (VLDL) cholesterol
Semaglutide 7.2 mg versus Placebo: Change in waist circumference
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=10% (yes/no)
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=15% (yes/no)
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=20% (yes/no)
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no)
Semaglutide 7.2 mg versus Placebo: Number of participants with HbA1c less than (<) 7.0% (53 millimoles per mole [mmol/mol])
Semaglutide 7.2 mg versus Placebo: Number of participants with HbA1c less than or equal to (<=) 6.5 % (48 mmol/mol)
Semaglutide 7.2 mg versus Placebo: Relative change in body weight

Trial Safety

Safety Progress

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

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

3 Treatment Groups

Semaglutide 7.2 mg
1 of 3
Semaglutide 2.4 mg
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

500 Total Participants · 3 Treatment Groups

Primary Treatment: Semaglutide 7.2 mg · Has Placebo Group · Phase 3

Semaglutide 7.2 mg
Drug
Experimental Group · 1 Intervention: Semaglutide · Intervention Types: Drug
Semaglutide 2.4 mg
Drug
Experimental Group · 1 Intervention: Semaglutide · Intervention Types: Drug
Placebo
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

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (week 0) to end of study (week 81)

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,403 Previous Clinical Trials
2,308,369 Total Patients Enrolled
117 Trials studying Obesity
127,158 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
45 Previous Clinical Trials
69,086 Total Patients Enrolled
12 Trials studying Obesity
40,355 Patients Enrolled for Obesity

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female and you qualify for the study.
You are 18 years or older at the time of providing consent.
You have reported a past failure in attempting to reduce body weight.
You have been diagnosed with T2D at least 180 days before the day of screening.
Your HbA1c is within the range of 7.0-10.0 percent (53-86 mmol/mol) as determined by a central laboratory at the start of the study.

Who else is applying?

What state do they live in?
Texas84.6%
Tennessee3.8%
California3.8%
Other7.7%
What portion of applicants met pre-screening criteria?
Met criteria92.3%
Did not meet criteria7.7%
Why did patients apply to this trial?
  • "Type 2 and fat"
  • "Need to loose weight"
  • "Hoping trial will help"
  • "I am overweight and my A1c is getting too high"
  • "Id like to control my diabetes and lose weight."
How many prior treatments have patients received?
057.1%
114.3%
3+28.6%
What questions have other patients asked about this trial?
  • "How often would I have to come to the facility? Would I administer the medication at home?"
  • "I don’t have a car and will need transportation. Will this study compensate me for my time and effort? What disqualifies are there for this study?"
What site did they apply to?
Novo Nordisk Investigational Site - Austin44.4%
Novo Nordisk Investigational Site33.3%
Other22.2%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 24 hours
Average response time
  • < 1 Day