STEP 10: Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05040971
• Collaborator: (none)
• Enrollment: 201
• Locations: 22
• Arms: 2
• Anticipated Duration (Months): 22.5
• Patients Per Site: 9.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes.

This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar.

Semaglutide is compared to a "dummy" medicine. The "dummy" medicine looks like semaglutide but has no effect on the body.

In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight.

Participants will either get semaglutide or "dummy" medicine - which treatment they get is decided by chance. Participants are 2 times as likely to get semaglutide as "dummy" medicine.

Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.

The study will last for about 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication.

Participants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Semaglutide 2.4 mg; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes
• Actual Study Start Date: Sep 6, 2021
• Anticipated Primary Completion Date: Jan 9, 2023
• Anticipated Study Completion Date: Jul 24, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide Participants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks	Drug: Semaglutide 2.4 mg; Administered subcutaneously (s.c., under the skin) once weekly as well as reduced-calorie diet and increased physical activity for 52 weeks. Doses gradually increased to 2.4 mg
Placebo Comparator: Placebo (semaglutide) Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks	Drug: Placebo; Administered subcutaneously once weekly (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 52 week

Outcome Measures

Primary Outcome Measures

1. Change in body weight [From randomisation (week 0) to end of treatment (week 52)]

   Percentage

2. Change to normoglycemia (Normoglycemia is defined as having both HbA1c below 6.0% (below 42 mmol/mol) and FPG below 5.5 mmol/L (below 99 mg/dL) [From randomisation (week 0) to end of treatment (week 52)]

   Count of subjects

Secondary Outcome Measures

1. Change in HbA1c (glycated haemoglobin) [From randomisation (week 0) to end of treatment (week 52)]

   Percentage-points

2. Change in FPG (fasting plasma glucose) [From randomisation (week 0) to end of treatment (week 52)]

   measured in mmol/L

3. Change in waist circumference [From randomisation (week 0) to end of treatment (week 52)]

   measured in cm

4. Change in systolic blood pressure [From randomisation (week 0) to end of treatment (week 52)]

   measured in mmHg

5. Change in lipids - Triglycerides [From randomisation (week 0) to end of treatment (week 52)]

   percentage

6. Change in lipids - Total cholesterol [From randomisation (week 0) to end of treatment (week 52)]

   percentage

7. Change in lipids - High density lipoprotein (HDL) cholesterol [From randomisation (week 0) to end of treatment (week 52)]

   percentage

8. Change in lipids - low density lipoprotein (LDL) cholesterol [From randomisation (week 0) to end of treatment (week 52)]

   percentage

9. Change in lipids - Very low density lipoprotein (VLDL) cholesterol [From randomisation (week 0) to end of treatment (week 52)]

   percentage

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female aged greater than or equal to 18 years at the time of signing informed consent.

• BMI greater than or equal to 30.0 kg/m^2

• Prediabetes defined as at least one of the following:

• HbA1c between 6.0 and 6.4 percent (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening.

• FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening.

Exclusion Criteria:

• History of type 1 or type 2 diabetes.

• Treatment with glucose-lowering agent(s) within 90 days before screening.

• HbA1c greater than or equal to 6.5 percent (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening.

• FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by central laboratory at screening.

A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.

• Treatment with any medication for the indication of obesity within the past 90 days before screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Calgary	Alberta	Canada	T2T 5C7
2	Novo Nordisk Investigational Site	Calgary	Alberta	Canada	T2V 4J2
3	Novo Nordisk Investigational Site	Surrey	British Columbia	Canada	V3Z 2N6
4	Novo Nordisk Investigational Site	Moncton	New Brunswick	Canada	E1G 1A7
5	Novo Nordisk Investigational Site	Brampton	Ontario	Canada	L6S 0C6
6	Novo Nordisk Investigational Site	Concord	Ontario	Canada	L4K 4M2
7	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8L 5G8
8	Novo Nordisk Investigational Site	Hamilton	Ontario	Canada	L8M 1K7
9	Novo Nordisk Investigational Site	London	Ontario	Canada	N5W 6A2
10	Novo Nordisk Investigational Site	Toronto	Ontario	Canada	M4P 1P2
11	Novo Nordisk Investigational Site	Toronto	Ontario	Canada	M6G 1M2
12	Novo Nordisk Investigational Site	Montreal	Quebec	Canada	H4N 2W2
13	Novo Nordisk Investigational Site	Montreal	Quebec	Canada	H4T 1Z9
14	Novo Nordisk Investigational Site	Sherbrooke	Quebec	Canada	J1H 5N4
15	Novo Nordisk Investigational Site	Terrebonne	Quebec	Canada	J6X 4P7
16	Novo Nordisk Investigational Site	Aarhus N		Denmark	8200
17	Novo Nordisk Investigational Site	Hvidovre		Denmark	2650
18	Novo Nordisk Investigational Site	Jyväskylä		Finland	40620
19	Novo Nordisk Investigational Site	University Of Helsinki		Finland	00014
20	Novo Nordisk Investigational Site	Madrid		Spain	28009
21	Novo Nordisk Investigational Site	Madrid		Spain	28040
22	Novo Nordisk Investigational Site	Sevilla		Spain	41010

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT05040971
• Other Study ID Numbers: NN9536-4734; U1111-1253-1956; 2020-002939-29
• First Posted: Sep 10, 2021
• Last Update Posted: Mar 23, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Prediabetic State

Study Results

No Results Posted as of Mar 23, 2022