Obesity
Conditions
Brief summary
The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a dummy medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study.
Interventions
DRUGSemaglutide 2.4 mg and NNC0165-1875 2.0 mg
NNC0165-1875 will be co-escalated once-weekly subcutaneously with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
DRUGSemaglutide 2.4 mg and placebo 2.0 mg
NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
DRUGSemaglutide 2.4 mg and NNC0165-1875 1.0 mg
NNC0165-1875 will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
DRUGSemaglutide 2.4 mg and placebo 1.0 mg
NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Intervention model description
Part 1: is a 16-week study were one group of participants will receive two doses of NNC0165-1875 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo. Part 2: is a 40-week study were one group of participants will receive one dose of NNC0165 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * Male or female, age above or equal to 18 years at the time of signing informed consent. * BMI 30.0-45.0 kg/m\^2 (both inclusive) at the screening visit.
Exclusion criteria
* HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening. * History of type 1 or type 2 diabetes mellitus. * Treatment with glucose-lowering agent(s) within 90 days before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Treatment-emergent Adverse Events (TEAEs) | Part 1: From time of dosing (day 1) to follow-up (week 24) | A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit. |
| Part 2b: Percentage Change in Body Weight | Part 2: Randomisation (week 32), end of treatment (week 48) | Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2b: Change in Body Weight (kg) | Part 2b: Randomisation (week 32), end of treatment (week 48) | Change in body weight (kg) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
| Part 2b: Change in Glycosylated Haemoglobin (HbA1c) | Part 2b: Randomisation (week 32), end of treatment (week 48) | Change in HbA1c from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Percentage point is calculated by subtraction of baseline HbA1c from HbA1c at end of treatment. |
| Part 2b: Change in Fasting Plasma Glucose (FPG) | Part 2b: Randomisation (week 32), end of treatment (week 48) | Change in FPG (measured in millimoles per liter \[mmol/l\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
| Part 2b: Change in Fasting Insulin | Part 2b: Randomisation (week 32), end of treatment (week 48) | Change in fasting insulin (measured in picomoles per liter \[pmol/l\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
| Part 2b: Change in Waist Circumference | Part 2b: Randomisation (week 32), end of treatment (week 48) | Change in waist circumference (measured in centimeter \[cm\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
| Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline) | Part 2b: Randomisation (week 32), end of treatment (week 48) | Relative change in total cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
| Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | Part 2b: Randomisation (week 32), end of treatment (week 48) | Relative change in HDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
| Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | Part 2b: Randomisation (week 32), end of treatment (week 48) | Relative change in LDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
| Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline) | Part 2b: Randomisation (week 32), end of treatment (week 48) | Relative change in VLDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
| Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline) | Part 2b: Randomisation (week 32), end of treatment (week 48) | Relative change in triglycerides (measured in mmol/l) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
| Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline) | Part 2b: Randomisation (week 32), end of treatment (week 48) | Relative change in free fatty acids (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
| Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs) | From randomisation (week 32) to end of the trial (week 56) | An AE is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an IMP, whether or not considered related to the IMP. All AEs reported here are TEAEs. A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visits or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit. The TEAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
| Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs) | From randomisation (week 32) to end of the trial (week 56) | A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
Countries
United States
Participant flow
Recruitment details
The trial was conducted at 14 sites in the United States.
Pre-assignment details
The trial consisted of part 1 and 2. Part 1: 24 weeks (16-week treatment + 8 week follow up). In part 1 participants received NNC0165-1875 1.0 milligrams (mg) / matching placebo or NNC0165-1875 2.0 mg / matching placebo with semaglutide 2.4 mg. Part 2 further consisted of open-label run-in part (part 2a) of 32 weeks where participants received semaglutide and part 2b of 16 weeks where participants received NNC0165-1875 or NNC0165-1875 placebo with semaglutide s.c. 2.4 mg and 8-week follow up.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg). | 8 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg). | 8 |
| Part 1: Placebo + Semaglutide 2.4 mg Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg). | 8 |
| Part 2 All Participants randomised in Part 2. | 96 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Part 2a: Run in Period (32 Weeks) | Adverse Event | 0 | 0 | 0 | 4 | 0 | 0 | 0 |
| Part 2a: Run in Period (32 Weeks) | Lost to Follow-up | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Part 2a: Run in Period (32 Weeks) | Other | 0 | 0 | 0 | 5 | 0 | 0 | 0 |
| Part 2a: Run in Period (32 Weeks) | Pregnancy | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Part 2a: Run in Period (32 Weeks) | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Part 2b (16 Weeks) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 3 | 1 | 0 |
Baseline characteristics
| Characteristic | Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 1: Placebo + Semaglutide 2.4 mg | Part 2 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 44 Years STANDARD_DEVIATION 12 | 45 Years STANDARD_DEVIATION 14 | 43 Years STANDARD_DEVIATION 13 | 50 Years STANDARD_DEVIATION 13 | 48.4 Years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 0 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 6 Participants | 8 Participants | 91 Participants | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 4 Participants | 16 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 4 Participants | 71 Participants | 80 Participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 3 Participants | 78 Participants | 91 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 5 Participants | 18 Participants | 29 Participants |
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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 96 | 0 / 47 | 0 / 8 | 0 / 28 |
| other Total, other adverse events | 8 / 8 | 8 / 8 | 8 / 8 | 69 / 96 | 36 / 47 | 7 / 8 | 16 / 28 |
| serious Total, serious adverse events | 0 / 8 | 1 / 8 | 0 / 8 | 2 / 96 | 2 / 47 | 0 / 8 | 0 / 28 |
Outcome results
Primary
Part 1: Number of Treatment-emergent Adverse Events (TEAEs)
A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.
Time frame: Part 1: From time of dosing (day 1) to follow-up (week 24)
Population: SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 1: Number of Treatment-emergent Adverse Events (TEAEs) | 56 Events |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 1: Number of Treatment-emergent Adverse Events (TEAEs) | 71 Events |
| Part 1: Placebo + Semaglutide 2.4 mg | Part 1: Number of Treatment-emergent Adverse Events (TEAEs) | 37 Events |
Primary
Part 2b: Percentage Change in Body Weight
Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: Part 2: Randomisation (week 32), end of treatment (week 48)
Population: Full analysis set (FAS) included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Percentage Change in Body Weight | -5.55 Percentage change in body weight | Standard Deviation 3.97 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Percentage Change in Body Weight | -3.06 Percentage change in body weight | Standard Deviation 5.46 |
Comparison: Week 48 responses were analysed using an analysis of covariance model with randomised treatment as factors and baseline body weight (kg) as covariate.p-value: 0.043795% CI: [-4.24, -0.06]ANCOVA
Secondary
Part 2b: Change in Body Weight (kg)
Change in body weight (kg) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Change in Body Weight (kg) | -4.54 kilograms (kg) | Standard Deviation 3.22 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Change in Body Weight (kg) | -2.23 kilograms (kg) | Standard Deviation 5.16 |
Secondary
Part 2b: Change in Fasting Insulin
Change in fasting insulin (measured in picomoles per liter \[pmol/l\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Change in Fasting Insulin | -14.10 pmol/l | Standard Deviation 39.31 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Change in Fasting Insulin | -8.10 pmol/l | Standard Deviation 47.22 |
Secondary
Part 2b: Change in Fasting Plasma Glucose (FPG)
Change in FPG (measured in millimoles per liter \[mmol/l\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Population: FAS included all partcipants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Change in Fasting Plasma Glucose (FPG) | 0.08 mmol/l | Standard Deviation 0.36 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Change in Fasting Plasma Glucose (FPG) | -0.02 mmol/l | Standard Deviation 0.42 |
Secondary
Part 2b: Change in Glycosylated Haemoglobin (HbA1c)
Change in HbA1c from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Percentage point is calculated by subtraction of baseline HbA1c from HbA1c at end of treatment.
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Change in Glycosylated Haemoglobin (HbA1c) | -0.17 Percentage point of HbA1c | Standard Deviation 0.17 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Change in Glycosylated Haemoglobin (HbA1c) | -0.17 Percentage point of HbA1c | Standard Deviation 0.14 |
Secondary
Part 2b: Change in Waist Circumference
Change in waist circumference (measured in centimeter \[cm\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Change in Waist Circumference | -4.80 cm | Standard Deviation 6.92 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Change in Waist Circumference | -2.69 cm | Standard Deviation 5.73 |
Secondary
Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an IMP, whether or not considered related to the IMP. All AEs reported here are TEAEs. A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visits or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit. The TEAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: From randomisation (week 32) to end of the trial (week 56)
Population: SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs) | 220 Events |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs) | 45 Events |
| Part 1: Placebo + Semaglutide 2.4 mg | Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs) | 56 Events |
Secondary
Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: From randomisation (week 32) to end of the trial (week 56)
Population: SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs) | 2 Events |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs) | 0 Events |
| Part 1: Placebo + Semaglutide 2.4 mg | Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs) | 0 Events |
Secondary
Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)
Relative change in free fatty acids (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline) | 0.87 Ratio of free fatty acids | Standard Deviation 0.39 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline) | 1.07 Ratio of free fatty acids | Standard Deviation 0.48 |
Secondary
Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
Relative change in HDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.02 Ratio of HDL cholesterol | Standard Deviation 0.12 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.08 Ratio of HDL cholesterol | Standard Deviation 0.12 |
Secondary
Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
Relative change in LDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 1.01 Ratio of LDL cholesterol | Standard Deviation 0.17 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 1.08 Ratio of LDL cholesterol | Standard Deviation 0.27 |
Secondary
Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)
Relative change in total cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline) | 1.00 Ratio of total cholesterol | Standard Deviation 0.11 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline) | 1.07 Ratio of total cholesterol | Standard Deviation 0.17 |
Secondary
Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)
Relative change in triglycerides (measured in mmol/l) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline) | 0.96 Ratio of triglycerides | Standard Deviation 0.26 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline) | 1.03 Ratio of triglycerides | Standard Deviation 0.26 |
Secondary
Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)
Relative change in VLDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: Part 2b: Randomisation (week 32), end of treatment (week 48)
Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg | Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline) | 0.96 Ratio of VLDL cholesterol | Standard Deviation 0.25 |
| Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg | Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline) | 1.04 Ratio of VLDL cholesterol | Standard Deviation 0.27 |