Semaglutide 7.2 mg for Obesity

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

Study Summary

This study will look at how much weight participants will lose 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. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

2 Primary · 36 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 Semaglutide 2.4 mg: Number of AEs
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs
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 lean body mass (%)
Semaglutide 7.2 mg versus Placebo: Change in lean body mass (liters)
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 total fat mass (%)
Semaglutide 7.2 mg versus Placebo: Change in total fat mass (liters)
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 visceral fat mass (%)
Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (liters)
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 >=25% (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 change in antihypertensive treatment (decrease, no change, increase)
Semaglutide 7.2 mg versus Placebo: Number of participants with change in glycaemic category (Normo-glycaemia, pre-diabetes, type 2 diabetes [T2D])
Semaglutide 7.2 mg versus Placebo: Number of participants with change in lipid-lowering treatment (decrease, no change, increase)
Semaglutide 7.2 mg versus Placebo: Relative change in body weight
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=20% (yes/no)
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=25% (yes/no)
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: 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

1400 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
2,307,469 Total Patients Enrolled
117 Trials studying Obesity
126,258 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
45 Previous Clinical Trials
68,186 Total Patients Enrolled
12 Trials studying Obesity
39,455 Patients Enrolled for Obesity

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are either male or female.
You are 18 or older at the time of consent.
You have attempted and not succeeded in losing weight through dieting.

Who else is applying?

What state do they live in?
Indiana25.0%
Florida25.0%
Texas25.0%
Other25.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
Why did patients apply to this trial?
  • "I'm struggling to lose weight."
  • "I have been on metformin and i exercise and pay attention to what I am consuming, but nothing seems to be budging. Mental health is suffering from my physical appearance"
How many prior treatments have patients received?
050.0%
150.0%
What site did they apply to?
Novo Nordisk Investigational Site100.0%