A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05486065 |
Recruitment Status :
Recruiting
First Posted : August 3, 2022
Last Update Posted : March 29, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: Semaglutide Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Investigation of Once-weekly Semaglutide S.C. Dose-Response in Patients With Type 2 Diabetes and Overweight - a Participant- and Investigator-blinded and Sponsor Open-label Study |
Actual Study Start Date : | August 8, 2022 |
Estimated Primary Completion Date : | November 6, 2023 |
Estimated Study Completion Date : | December 13, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Semaglutide 2 mg
Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection.
|
Drug: Semaglutide
Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period. |
Placebo Comparator: Semaglutide placebo 2 mg
Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection.
|
Drug: Placebo
Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period. |
Experimental: Semaglutide 8 mg
Participants will receive once-weekly semaglutide 8 mg s.c. injection.
|
Drug: Semaglutide
Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period. |
Placebo Comparator: Semaglutide placebo 8 mg
Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection.
|
Drug: Placebo
Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period. |
Experimental: Semaglutide 16 mg
Participants will receive once-weekly semaglutide 16 mg s.c. injection.
|
Drug: Semaglutide
Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period. |
Placebo Comparator: Semaglutide placebo 16 mg
Participants will receive once-weekly semaglutide placebo 16 mg s.c. injection.
|
Drug: Placebo
Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period. |
- Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 40) ]Measured as percentage
- Change in Body Weight [ Time Frame: From baseline (week 0) to end of treatment (week 40) ]Measured as kilogram
- Number of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From baseline (week 0) to end of study (week 49) ]Measured as count of events
- Number of Treatment-emergent Severe Hypoglycaemic Episodes [ Time Frame: From baseline (week 0) to end of study (week 49) ]Measured as number of episodes

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female.
- Aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus greater than equal to (≥) 180 days prior to the day of screening.
- Glycosylated haemoglobin (HbA1c) of 7.0 - 10.5 percentage (%) [53 - 91 millimoles per mole (mmol/mol)] (both inclusive).
- Body Mass Index (BMI) ≥ 27.0 kilograms per meter square (kg/m^2).
- Stable daily dose(s) ≥ 90 days prior to the day of screening of any metformin formulations.
Exclusion Criteria:
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (<) 30 milliliters per minute (mL/min)/1.73 meter square (m^2) at screening.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05486065
Contact: Novo Nordisk | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |

Study Director: | Clinical Transparency (dept. 2834) | Novo Nordisk A/S |
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT05486065 |
Other Study ID Numbers: |
NN9535-4984 U1111-1271-9209 ( Other Identifier: World Health Organization (WHO) ) 2022-000882-41 ( EudraCT Number ) |
First Posted: | August 3, 2022 Key Record Dates |
Last Update Posted: | March 29, 2023 |
Last Verified: | March 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | According to the Novo Nordisk disclosure commitment on novonordisk-trials.com |
URL: | http://novonordisk-trials.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus Diabetes Mellitus, Type 2 Overweight Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Body Weight |