Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes
Interventions
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.
Administered subcutaneously ( s.c., under the skin) once daily.
Sponsors
Study design
Eligibility
Inclusion criteria
* Male or female, age at least 18 years at the time of signing informed consent. * Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening * HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive) * BMI: 25.0 - 40.0 kg/m\^2 (both inclusive)
Exclusion criteria
* Simultaneous participation in any other clinical trial of an investigational medicinal product * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle) * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days) * Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids) * History of pancreatitis (acute or chronic) * Screening calcitonin above or equal to 50 ng/L * Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC) * Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology) * Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack * Currently planned coronary, carotid or peripheral artery revascularisation * Patients presently classified as being in New York Heart Association (NYHA) Class III or IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (Glycosylated Haemoglobin) | Week 0, week 26 | Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | Week 0, Week 26 | Estimated mean change from baseline in FPG at week 26. The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy. |
| Body Weight Change | Week 0, Week 26 | The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy. |
| Change in Systolic and Diastolic Blood Pressure | Week 0, Week 26 | The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy. |
Countries
Austria, Canada, Czechia, Germany, Malaysia, Russia, Serbia, South Africa, United Kingdom, United States
Participant flow
Recruitment details
The trial was conducted at 139 sites in 10 countries as follows: Austria: 3 sites; Canada: 8 sites; Czech Republic: 9 sites; Germany: 7 sites; Malaysia: 5 sites; Russian Federation: 7 sites; Serbia: 9 sites; South Africa: 7 sites; United Kingdom: 13 sites; United States: 71 sites.
Pre-assignment details
Of the 706 subjects randomised in the trial, 705 were exposed to trial products and 1 randomised subject withdrew prior to exposure.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide 0.05 mg/Day Participants received semaglutide 0.05 mg subcutaneous (sc) injection once daily for 26 weeks. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. | 64 |
| Semaglutide 0.1 mg/Day Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. | 63 |
| Semaglutide 0.2 mg/Day Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks and then semaglutide 0.2 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. | 65 |
| Semaglutide 0.3 mg/Day Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. | 63 |
| Liraglutide 0.3 mg/Day Participants received liraglutide 0.3 mg sc injection once daily for 26 weeks. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. | 64 |
| Liraglutide 0.6 mg/Day Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. | 64 |
| Liraglutide 1.2 mg/Day Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks and then liraglutide 1.2 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. | 64 |
| Liraglutide 1.8 mg/Day Participants received liraglutide 0.3 mg sc injection once daily for 4 weeks followed by liraglutide 0.6 mg once daily for next 4 weeks followed by liraglutide 1.2 mg once daily for next 4 weeks and then liraglutide 1.8 mg once daily upto week 26. Liraglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. | 65 |
| Placebo Participants received placebo (the volume matched the volume used for the specific dose of semaglutide or liraglutide) sc injection once daily upto 26 weeks. Placebo injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. | 129 |
| Semaglutide Flexible Participants received semaglutide 0.05 mg sc injection once daily for 4 weeks followed by semaglutide 0.1 mg once daily for next 4 weeks followed by 0.2 mg once daily for next 4 weeks and then semaglutide 0.3 mg once daily upto week 26. Semaglutide injection was administered in the thigh, abdomen, or upper arm, preferably around the same time of the day irrespective of meals. Participants were allowed to follow a more flexible dose-escalation regimen based on gastrointestinal tolerability. Semaglutide dose levels could be reduced in participants with poor gastrointestinal tolerability depending on investigator's assessment. | 64 |
| Total | 705 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 3 | 1 | 1 | 3 | 1 | 3 | 1 |
| Overall Study | Missing follow-up information | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Unclassified | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 1 | 3 | 2 | 1 | 2 | 1 | 3 | 3 | 1 |
| Overall Study | Withdrawal from trial before exposure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Semaglutide 0.05 mg/Day | Semaglutide 0.1 mg/Day | Semaglutide 0.2 mg/Day | Semaglutide 0.3 mg/Day | Liraglutide 0.3 mg/Day | Liraglutide 0.6 mg/Day | Liraglutide 1.2 mg/Day | Liraglutide 1.8 mg/Day | Placebo | Semaglutide Flexible | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 57.53 years STANDARD_DEVIATION 9.8 | 57.51 years STANDARD_DEVIATION 10 | 58.37 years STANDARD_DEVIATION 9.58 | 54.76 years STANDARD_DEVIATION 9.66 | 57.20 years STANDARD_DEVIATION 10.78 | 59.45 years STANDARD_DEVIATION 9.77 | 53.73 years STANDARD_DEVIATION 11.35 | 55.82 years STANDARD_DEVIATION 9.19 | 57.08 years STANDARD_DEVIATION 9.25 | 54.81 years STANDARD_DEVIATION 9.7 | 56.67 years STANDARD_DEVIATION 9.94 |
| Body weight | 93.44 kg STANDARD_DEVIATION 18.27 | 92.40 kg STANDARD_DEVIATION 17.2 | 98.07 kg STANDARD_DEVIATION 17.92 | 94.82 kg STANDARD_DEVIATION 17.84 | 92.25 kg STANDARD_DEVIATION 17.48 | 92.68 kg STANDARD_DEVIATION 16.46 | 96.67 kg STANDARD_DEVIATION 18.28 | 93.40 kg STANDARD_DEVIATION 19.34 | 93.98 kg STANDARD_DEVIATION 17.75 | 95.29 kg STANDARD_DEVIATION 15.43 | 94.28 kg STANDARD_DEVIATION 17.61 |
| Diastolic blood pressure | 80.06 mmHg STANDARD_DEVIATION 8.9 | 79.71 mmHg STANDARD_DEVIATION 8.56 | 80.48 mmHg STANDARD_DEVIATION 8.87 | 81.41 mmHg STANDARD_DEVIATION 8.05 | 81.83 mmHg STANDARD_DEVIATION 6.98 | 81.28 mmHg STANDARD_DEVIATION 6.9 | 82.98 mmHg STANDARD_DEVIATION 6.94 | 80.66 mmHg STANDARD_DEVIATION 7.62 | 80.98 mmHg STANDARD_DEVIATION 8 | 81.89 mmHg STANDARD_DEVIATION 8.4 | 81.11 mmHg STANDARD_DEVIATION 7.96 |
| Fasting plasma glucose | 9.26 mmol/L STANDARD_DEVIATION 2.6 | 8.97 mmol/L STANDARD_DEVIATION 2.22 | 9.20 mmol/L STANDARD_DEVIATION 2.28 | 9.67 mmol/L STANDARD_DEVIATION 2.56 | 9.32 mmol/L STANDARD_DEVIATION 2.54 | 9.34 mmol/L STANDARD_DEVIATION 2.33 | 9.91 mmol/L STANDARD_DEVIATION 2.7 | 9.18 mmol/L STANDARD_DEVIATION 2.45 | 9.67 mmol/L STANDARD_DEVIATION 2.98 | 9.82 mmol/L STANDARD_DEVIATION 2.66 | 9.45 mmol/L STANDARD_DEVIATION 2.59 |
| HbA1c (glycosylated haemoglobin) | 7.87 percentage of HbA1c STANDARD_DEVIATION 0.71 | 7.91 percentage of HbA1c STANDARD_DEVIATION 0.83 | 7.96 percentage of HbA1c STANDARD_DEVIATION 0.82 | 8.23 percentage of HbA1c STANDARD_DEVIATION 0.8 | 8.06 percentage of HbA1c STANDARD_DEVIATION 0.86 | 8.12 percentage of HbA1c STANDARD_DEVIATION 0.81 | 8.14 percentage of HbA1c STANDARD_DEVIATION 0.87 | 8.07 percentage of HbA1c STANDARD_DEVIATION 0.85 | 8.12 percentage of HbA1c STANDARD_DEVIATION 0.87 | 8.10 percentage of HbA1c STANDARD_DEVIATION 0.91 | 8.06 percentage of HbA1c STANDARD_DEVIATION 0.84 |
| Sex: Female, Male Female | 31 Participants | 28 Participants | 22 Participants | 31 Participants | 35 Participants | 32 Participants | 30 Participants | 32 Participants | 57 Participants | 28 Participants | 326 Participants |
| Sex: Female, Male Male | 33 Participants | 35 Participants | 43 Participants | 32 Participants | 29 Participants | 32 Participants | 34 Participants | 33 Participants | 72 Participants | 36 Participants | 379 Participants |
| Systolic blood pressure | 133.70 mmHg STANDARD_DEVIATION 15.14 | 130.97 mmHg STANDARD_DEVIATION 14.92 | 131.34 mmHg STANDARD_DEVIATION 12.55 | 132.08 mmHg STANDARD_DEVIATION 11.69 | 134.02 mmHg STANDARD_DEVIATION 11.3 | 132.41 mmHg STANDARD_DEVIATION 12.37 | 134.20 mmHg STANDARD_DEVIATION 12.73 | 131.02 mmHg STANDARD_DEVIATION 11.86 | 132.17 mmHg STANDARD_DEVIATION 14.26 | 132.70 mmHg STANDARD_DEVIATION 12.74 | 132.43 mmHg STANDARD_DEVIATION 13.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 31 / 64 | 34 / 63 | 39 / 65 | 42 / 63 | 33 / 64 | 27 / 64 | 35 / 64 | 35 / 65 | 0 / 129 | 44 / 64 |
| serious Total, serious adverse events | 7 / 64 | 3 / 63 | 2 / 65 | 2 / 63 | 1 / 64 | 2 / 64 | 2 / 64 | 7 / 65 | 0 / 129 | 4 / 64 |
Outcome results
Change in HbA1c (Glycosylated Haemoglobin)
Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Time frame: Week 0, week 26
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.05 mg/Day | Change in HbA1c (Glycosylated Haemoglobin) | -0.97 percentage of glycosylated haemoglobin | Standard Deviation 0.85 |
| Semaglutide 0.1 mg/Day | Change in HbA1c (Glycosylated Haemoglobin) | -1.30 percentage of glycosylated haemoglobin | Standard Deviation 1.03 |
| Semaglutide 0.2 mg/Day | Change in HbA1c (Glycosylated Haemoglobin) | -1.65 percentage of glycosylated haemoglobin | Standard Deviation 0.79 |
| Semaglutide 0.3 mg/Day | Change in HbA1c (Glycosylated Haemoglobin) | -1.96 percentage of glycosylated haemoglobin | Standard Deviation 0.95 |
| Liraglutide 0.3 mg/Day | Change in HbA1c (Glycosylated Haemoglobin) | -0.50 percentage of glycosylated haemoglobin | Standard Deviation 0.93 |
| Liraglutide 0.6 mg/Day | Change in HbA1c (Glycosylated Haemoglobin) | -0.88 percentage of glycosylated haemoglobin | Standard Deviation 0.9 |
| Liraglutide 1.2 mg/Day | Change in HbA1c (Glycosylated Haemoglobin) | -0.86 percentage of glycosylated haemoglobin | Standard Deviation 0.92 |
| Liraglutide 1.8 mg/Day | Change in HbA1c (Glycosylated Haemoglobin) | -1.32 percentage of glycosylated haemoglobin | Standard Deviation 0.78 |
| Placebo | Change in HbA1c (Glycosylated Haemoglobin) | -0.05 percentage of glycosylated haemoglobin | Standard Deviation 0.9 |
| Semaglutide Flexible | Change in HbA1c (Glycosylated Haemoglobin) | -1.72 percentage of glycosylated haemoglobin | Standard Deviation 0.97 |
Body Weight Change
The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Time frame: Week 0, Week 26
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.05 mg/Day | Body Weight Change | -2.75 kg | Standard Deviation 2.82 |
| Semaglutide 0.1 mg/Day | Body Weight Change | -4.36 kg | Standard Deviation 4.24 |
| Semaglutide 0.2 mg/Day | Body Weight Change | -6.70 kg | Standard Deviation 4.57 |
| Semaglutide 0.3 mg/Day | Body Weight Change | -8.23 kg | Standard Deviation 5.34 |
| Liraglutide 0.3 mg/Day | Body Weight Change | -1.48 kg | Standard Deviation 3.06 |
| Liraglutide 0.6 mg/Day | Body Weight Change | -1.81 kg | Standard Deviation 3.06 |
| Liraglutide 1.2 mg/Day | Body Weight Change | -1.78 kg | Standard Deviation 3.41 |
| Liraglutide 1.8 mg/Day | Body Weight Change | -3.68 kg | Standard Deviation 4.26 |
| Placebo | Body Weight Change | -1.22 kg | Standard Deviation 3.42 |
| Semaglutide Flexible | Body Weight Change | -6.60 kg | Standard Deviation 4.98 |
Change in Fasting Plasma Glucose (FPG)
Estimated mean change from baseline in FPG at week 26. The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Time frame: Week 0, Week 26
Population: Full analyses set. For Semaglutide flexible arm, data was available only for 63 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.05 mg/Day | Change in Fasting Plasma Glucose (FPG) | -2.09 mmol/L | Standard Deviation 1.96 |
| Semaglutide 0.1 mg/Day | Change in Fasting Plasma Glucose (FPG) | -2.08 mmol/L | Standard Deviation 2.23 |
| Semaglutide 0.2 mg/Day | Change in Fasting Plasma Glucose (FPG) | -2.64 mmol/L | Standard Deviation 2.07 |
| Semaglutide 0.3 mg/Day | Change in Fasting Plasma Glucose (FPG) | -3.53 mmol/L | Standard Deviation 2.2 |
| Liraglutide 0.3 mg/Day | Change in Fasting Plasma Glucose (FPG) | -1.33 mmol/L | Standard Deviation 2.06 |
| Liraglutide 0.6 mg/Day | Change in Fasting Plasma Glucose (FPG) | -1.56 mmol/L | Standard Deviation 1.74 |
| Liraglutide 1.2 mg/Day | Change in Fasting Plasma Glucose (FPG) | -1.51 mmol/L | Standard Deviation 2.41 |
| Liraglutide 1.8 mg/Day | Change in Fasting Plasma Glucose (FPG) | -1.92 mmol/L | Standard Deviation 2.34 |
| Placebo | Change in Fasting Plasma Glucose (FPG) | -0.54 mmol/L | Standard Deviation 2.45 |
| Semaglutide Flexible | Change in Fasting Plasma Glucose (FPG) | -3.40 mmol/L | Standard Deviation 2.84 |
Change in Systolic and Diastolic Blood Pressure
The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Time frame: Week 0, Week 26
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 0.05 mg/Day | Change in Systolic and Diastolic Blood Pressure | Systolicblood pressure | -5.74 mmHg | Standard Deviation 12.3 |
| Semaglutide 0.05 mg/Day | Change in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -0.60 mmHg | Standard Deviation 8.78 |
| Semaglutide 0.1 mg/Day | Change in Systolic and Diastolic Blood Pressure | Systolicblood pressure | -2.77 mmHg | Standard Deviation 13.21 |
| Semaglutide 0.1 mg/Day | Change in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | 0.66 mmHg | Standard Deviation 8.26 |
| Semaglutide 0.2 mg/Day | Change in Systolic and Diastolic Blood Pressure | Systolicblood pressure | -4.25 mmHg | Standard Deviation 12.24 |
| Semaglutide 0.2 mg/Day | Change in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -1.62 mmHg | Standard Deviation 9.38 |
| Semaglutide 0.3 mg/Day | Change in Systolic and Diastolic Blood Pressure | Systolicblood pressure | -9.85 mmHg | Standard Deviation 11.58 |
| Semaglutide 0.3 mg/Day | Change in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -4.02 mmHg | Standard Deviation 8.56 |
| Liraglutide 0.3 mg/Day | Change in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -1.77 mmHg | Standard Deviation 7.37 |
| Liraglutide 0.3 mg/Day | Change in Systolic and Diastolic Blood Pressure | Systolicblood pressure | -3.77 mmHg | Standard Deviation 9.79 |
| Liraglutide 0.6 mg/Day | Change in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -1.89 mmHg | Standard Deviation 8.2 |
| Liraglutide 0.6 mg/Day | Change in Systolic and Diastolic Blood Pressure | Systolicblood pressure | -3.20 mmHg | Standard Deviation 10.89 |
| Liraglutide 1.2 mg/Day | Change in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -0.60 mmHg | Standard Deviation 6.78 |
| Liraglutide 1.2 mg/Day | Change in Systolic and Diastolic Blood Pressure | Systolicblood pressure | -4.69 mmHg | Standard Deviation 12.73 |
| Liraglutide 1.8 mg/Day | Change in Systolic and Diastolic Blood Pressure | Systolicblood pressure | -2.99 mmHg | Standard Deviation 11.94 |
| Liraglutide 1.8 mg/Day | Change in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | 0.63 mmHg | Standard Deviation 8.13 |
| Placebo | Change in Systolic and Diastolic Blood Pressure | Systolicblood pressure | -2.34 mmHg | Standard Deviation 11.4 |
| Placebo | Change in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -0.61 mmHg | Standard Deviation 8.5 |
| Semaglutide Flexible | Change in Systolic and Diastolic Blood Pressure | Systolicblood pressure | -6.62 mmHg | Standard Deviation 14.02 |
| Semaglutide Flexible | Change in Systolic and Diastolic Blood Pressure | Diastolic blood pressure | -1.69 mmHg | Standard Deviation 8.25 |