Common use of Number of Study Participants Clause in Contracts

Number of Study Participants. There will be about 18 people joining this part of the study. You will be in this study for about 77 days. This does not include the time between screening and dosing, which can be up to 28 days. This part of the study involves: • 1 outpatient run-in period (4 weeks) with 4 outpatient visits to the Clinical Research Unit (CRU) • 1 dosing period during 1 continuous admission. 23 overnight stays at CRU. You will not be able to leave the CRU during that time • 1 follow-up visit to the CRU about 7 days after the last dose • 1 follow-up phone call about 4 weeks after the last dose Your eligibility to take part in another study depends on information from this study. You may be eligible to receive a different study drug in another study as soon as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. The dose of the study drug that will be used to treat people is not yet known. The dose of study drug in this part of the study will be determined based on information from the previous dosing groups. Dosing is planned as follows: DOSING GROUP NUMBER OF PARTICIPANTS STUDY DAYS -35 to -29 -28 to -22 -21 to -15 -14 to -8 -7 to -1 1 to 14 1 18 0.6 mg Saxenda 1.2 mg Saxenda 1.8 mg Saxenda 2.4 mg Saxenda 3 mg Saxenda 3 mg Saxenda + TBD* mg study drug or placebo *TBD – to be determined. Dosing for this part of the study will be based on data from the earlier dosing groups. It will be randomly assigned, like the flip of a coin, who receives either study drug or placebo You have about a 1 in 3 chance of being on placebo during the study. On study Day -35, you will visit the CRU for your first injection of Saxenda. It will be given to you by a qualified member of the study staff. Saxenda is given in the abdomen, upper thighs, or upper arms. You will be instructed on how to self-administer Saxenda at home during the 4 week run-in period. You will be given sufficient supplies for dosing at home and instructions about food and beverages relative to the timing of your once daily injections. You will also be instructed on how to store the medication. You will be given a dosing diary to record the dosing time of each dose given at home. You will return to the CRU every week during the outpatient run-in period (Study Days -28, -21, and -14). You will bring your completed dosing diary with you at the time of these visits. During these visits, Saxenda will be administered by the CRU staff and you will be given sufficient supplies for dosing at home. On Study Day -7, you will be admitted to the CRU to continue Saxenda dosing before beginning dosing with study drug or placebo on Study Day 1. Saxenda doses while in the CRU will be given by the study staff, including Day -7 when you check in for the study. You will continue to receive a daily injection of Saxenda through Day -1 of the study. On Day -1 you will fast overnight for at least 10 hours before an OGTT. It will be done at about the same time as scheduled for Day 4. From Days 1 to 14, you will continue to receive Saxenda as a daily injection and you will also receive oral doses of study drug or placebo. On Days 1 – 3 and 5 - 14, you will fast overnight for at least 10 hours before receiving a standard breakfast. Breakfast will be provided about 30 minutes before dosing. It should be completely eaten within 20 minutes. Dosing will take place about 10 minutes after completing breakfast. Saxenda dosing will be within 5 minutes of study drug or placebo dosing. On Day 4, you will fast overnight for at least 10 hours before receiving a single oral dose of study drug or placebo. About 30 minutes after dosing, an OGTT will be done. The timing of the OGTT may be changed based on the study drug blood levels from earlier in the study. An OGTT involves drinking an 8 oz solution containing 75 grams of sugar. It measures how well the body can break down sugar. A blood sample is taken before drinking the solution and approximately 4½ hours after. During this time period, blood samples will be collected approximately every 30 minutes. Both you and the study staff will not know whether you are receiving the study drug or placebo. In case of a medical emergency, the study investigator can find out what you have received if considered necessary. The doses of study drug and placebo that you receive may be compounded in our pharmacy for use in this part of the study. Compounded means that the ingredients are added together and mixed to make the final dose(s). All oral doses will be taken with water. The total fluid volume of doses and water will be about 8 oz (1cup). All doses must be completely swallowed. We will check your mouth after each dose to make sure the study drug or placebo have been swallowed This is a research study. The study drug and Saxenda will be given to you only during this study and not after the study is over. Before any study procedures begin, you will be asked to read, sign, and date this consent document.

Number of Study Participants. There will be about 18 people joining 30 participants taking part in this part of the study. You will be in this study for about 77 45 days. This does not include the time between screening (the period during which your eligibility for participation in this study will be assessed) and dosing, which can be up to 28 days. This part of the study involves: • 1 outpatient run-in period ( 4 weeks) with 4 outpatient visits to dosing periods during one continuous admission  18 overnight stays at the Clinical Research Unit (CRU) • 1 dosing period during 1 continuous admission. 23 overnight stays at CRU). You will not be able to leave the CRU during that time • 1 follow-up visit to the CRU about 7 days after the last dose •  1 follow-up phone call about 4 weeks after the last dose There will be at least 5 days between each dose. Your eligibility to take part in another study depends on information from this study and the ongoing study. You may be eligible to receive a different study drug in another study as soon as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer longer, which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. The dose of the study drug that will be used to treat people with cancer is not yet known. The dose One group of study drug participants is planned. Dosing in this part of the study will be determined based on information from the previous dosing groups. Dosing is planned as follows: DOSING GROUP NUMBER OF PARTICIPANTS STUDY DAYS -35 to -29 -28 to -22 -21 to -15 -14 to -8 -7 to -1 1 to 14 1 18 0.6 Study Treatment A: 300 mg Saxenda 1.2 mg Saxenda 1.8 mg Saxenda 2.4 mg Saxenda 3 mg Saxenda 3 mg Saxenda + TBD* mg of study drug or placebo *TBD – (two 125 mg and two 25 mg tablets) IR MST faster dissolution (faster dissolving), fasted (without food) Study Treatment B: 300 mg of study drug (two 125 mg and two 25 mg tablets) IR MST moderate dissolution, fasted Study Treatment C: 300 mg of study drug (four 75 mg tablets) IR DC batch moderate dissolution, fasted Study Treatment D: 300 mg of study drug (four 75 mg tablets) IR DC Continuous (slower dissolution), fasted Study Treatment E: 300 mg of study drug (four 75 mg tablets) IR DC Batch moderate dissolution, fed (with food) An IR (immediate release) formulation releases the active ingredients of a drug in a short period of time. MST (material sparing tablet) means that these tablets were developed on a small scale in order to be determinedkeep the use of materials low. Dosing for this part of the DC (direct compression) is a manufacturing process. Your study will be based on data from the earlier dosing groups. It treatment sequence will be randomly assigned, like the flip pulling a number out of a coin, who receives either hat. Both you and the study staff will know what you are receiving. The study drug or placebo You have about a 1 in 3 chance of being on placebo during the studywill be given orally (by mouth). On study Day -351 of each period, you will visit the CRU for your first injection receive a single oral dose of Saxenda. It will be given to you by a qualified member of the study staff. Saxenda is given in the abdomen, upper thighs, or upper armsdrug. You will be instructed on how to self-administer Saxenda at home during the 4 week run-in period. You will be given sufficient supplies for dosing at home and instructions about food and beverages relative to the timing of your once daily injections. You will also be instructed on how to store the medication. You will be given a dosing diary to record the dosing time of each dose given at home. You will return to the CRU every week during the outpatient run-in period (Study Days -28, -21, and -14). You will bring your completed dosing diary with you at the time of these visits. During these visits, Saxenda will be administered by the CRU staff and you will be given sufficient supplies for dosing at home. On Study Day -7, you will be admitted to the CRU to continue Saxenda dosing before beginning dosing with study drug or placebo on Study Day 1. Saxenda doses while in the CRU will be given by the study staff, including Day -7 when you check in for the study. You will continue to receive a daily injection of Saxenda through Day -1 of the study. On Day -1 you will fast overnight (nothing to eat or drink except water) for at least 10 hours before an OGTTdosing or beginning breakfast. It will be done at about When dosing in the same time as scheduled for Day 4. From Days 1 to 14fed state, you will continue to receive Saxenda as a daily injection and you will also receive oral doses of study drug or placebo. On Days 1 – 3 and 5 - 14, you will fast overnight for at least 10 hours before receiving a standard breakfast. Breakfast will be provided served breakfast about 30 minutes before dosing. It Breakfast should be completely eaten within 20 minutes. Dosing will take place about follow within 10 minutes after of completing breakfast. Saxenda When dosing will be within 5 minutes of study drug or placebo dosing. On Day 4in the fasting state, you will fast overnight for at least 10 hours before receiving not receive breakfast on Day 1 of all fasted periods. An example of a single oral dose high-fat breakfast includes: 2 eggs fried in butter, 2 strips of study drug or placebopork bacon, 2 slices of toast with butter, 4 oz. About 30 minutes after dosingof hash brown potatoes, an OGTT will be doneand 8 oz. The timing of whole milk. All of the OGTT may breakfast items should be changed based on the study drug blood levels from earlier eaten in the study. An OGTT involves drinking an 8 oz solution containing 75 grams of sugar. It measures how well the body can break down sugar. A blood sample is taken before drinking the solution and approximately 4½ hours after. During this time period, blood samples will be collected approximately every 30 20 minutes. Both If you and the study staff will not know whether agree to be in this study, you are receiving agreeing to eat all the study drug or placebo. In case of a medical emergency, the study investigator can find out what you have received if considered necessary. The doses of study drug and placebo that you receive may be compounded in our pharmacy for use food listed in this part of the studymenu. Compounded means that the ingredients are added together and mixed to make the final dose(s). All oral doses Each dose will be taken with about 8 oz of water. The total fluid volume of doses and water will be about 8 oz (1cup). All doses must be completely swallowedswallowed whole. We will check your mouth after each dose to make sure the study drug or placebo have has been swallowed swallowed. This is a research study. The study drug and Saxenda drugs will be given to you only during this study and not after the study is over. Before any study procedures begin, you will be asked to read, sign, and date this consent document.

Number of Study Participants. There will be about 18 12 people joining taking part in this part of the study. You will be in this part of the study for up to about 77 42 days. This does not include the time between screening and dosing, which can be up to 28 days. This part of the study involves: • 2 dosing periods during 1 outpatient run-in period (4 weeks) with 4 outpatient visits to continuous admission • 12 overnight stays at the Clinical Research Unit (CRU) • 1 dosing period during 1 continuous admission. 23 overnight stays at CRU. o You will not be able to leave the CRU during that time • 1 follow-up visit to the CRU about 7 days after the last dose • 1 follow-up phone call about 4 weeks after the last dose There will be at least 7 days between each dose of study drug. Eligibility to Participate in Another Drug Study Your eligibility to take part in another study depends on information from the previous study and this study. You may be eligible to receive a different study drug in another study as soon early as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. The dose of the study drug that will be used to treat people is not yet known. The dose One group of study drug in participants is planned for this part of the study will be determined based on information from the previous dosing groupsstudy. Dosing for this study is planned as follows: DOSING GROUP NUMBER OF PARTICIPANTS STUDY DAYS -35 to -29 -28 to -22 -21 to -15 -14 to -8 -7 to -1 Day 1 to 14 1 18 0.6 Days 1-3 Day 4 Days 5-7 12 300 mg Saxenda 1.2 mg Saxenda 1.8 mg Saxenda 2.4 mg Saxenda 3 mg Saxenda 3 mg Saxenda + TBD* mg of study drug or placebo *TBD – to be determined. Dosing for this part 200 mg of the study will be based on data from the earlier dosing groups. It will be randomly assigned, like the flip itraconazole 200 mg of a coin, who receives either itraconazole + 300 mg of study drug or placebo You have about a 200 mg of itraconazole On Day 1 in 3 chance of being on placebo during the study. On study Day -35, Period 1 you will visit the CRU for your first injection receive a single oral dose of Saxenda. It will be 300 mg of study drug, given to you by as a qualified member of the study staff. Saxenda is given in the abdomen, upper thighs, or upper armstablet. You will be instructed on how to self-administer Saxenda at home during the 4 week run-in period. You will be given sufficient supplies for dosing at home and instructions about food and beverages relative to the timing of your once daily injections. You will also be instructed on how to store the medication. You will be given a dosing diary to record the dosing time of each dose given at home. You will return to the CRU every week during the outpatient run-in period (Study Days -28, -21, and -14). You will bring your completed dosing diary with you at the time of these visits. During these visits, Saxenda will be administered by the CRU staff and you will be given sufficient supplies for dosing at home. On Study Day -7, you will be admitted to the CRU to continue Saxenda dosing before beginning dosing with study drug or placebo on Study Day 1. Saxenda doses while in the CRU will be given by the study staff, including Day -7 when you check in for the study. You will continue to receive a daily injection of Saxenda through Day -1 of the study. On Day -1 you will fast overnight (nothing to eat or drink except water) for at least 10 hours before an OGTTdosing. It will be done at about the same time as scheduled for Day 4. From On Days 1 to 141-3 and 5-7 of Period 2 (Days 5-7 and 9-11 overall), you will continue to receive Saxenda as a daily injection and you will also receive oral doses of study drug or placebo. On Days 1 – 3 and 5 - 14, you will fast overnight for at least 10 hours before receiving a standard breakfast. Breakfast will be provided about 30 minutes before dosing. It should be completely eaten within 20 minutes. Dosing will take place about 10 minutes after completing breakfast. Saxenda dosing will be within 5 minutes of study drug or placebo dosing. On Day 4, you will fast overnight for at least 10 hours before receiving a single oral dose of study drug or placebo200 mg of itraconazole, given as a liquid. About 30 minutes You will fast for at least 4 hours before dosing with itraconazole. On Day 4 of Period 2 (Day 8 overall), you will receive a single oral dose of 200 mg of itraconazole after dosing, an OGTT overnight fast of at least 10 hours. You will be done. The timing also receive a single oral dose of the OGTT may be changed based on the study drug blood levels from earlier in the study. An OGTT involves drinking an 8 oz solution containing 75 grams of sugar. It measures how well the body can break down sugar. A blood sample is taken before drinking the solution and approximately 4½ hours after. During this time period, blood samples will be collected approximately every 30 minutes. Both you and the study staff will not know whether you are receiving the study drug or placebo. In case of a medical emergency, the study investigator can find out what you have received if considered necessary. The doses 300 mg of study drug immediately after itraconazole dosing. There will be 4 days between study drug dosing in Period 1 and placebo that you receive may be compounded the start of itraconazole dosing in our pharmacy for use in this part of the study. Compounded means that the ingredients are added together and mixed to make the final dose(s)Period 2. All oral doses will be taken with water. The total fluid volume of the doses of itraconazole and water will be about 8 oz oz. (1cup1 cup). Study drug will be given with about 8 oz. of water. It must be swallowed whole. All doses must be completely swallowed. We will check your mouth after each dose to make sure the study drug or placebo have itraconazole has been swallowed swallowed. This is a research study. The study drug and Saxenda itraconazole will be given to you only during this study and not after the study is over. Before any study procedures begin, you will be asked to read, sign, and date this consent document.

Number of Study Participants. This study is being done at about 2 different study sites in 2 countries. There will be about 18 people joining up to 6 male participants in this part of the study. You will be in this study for about 77 38 days. This does not include the time between screening and dosing, which can be up to 28 days. This part of the study involves: •  1 outpatient run-in dosing period (4 weeks) with 4 outpatient visits to  12 overnight stays at the Clinical Research Unit (CRU) • 1 dosing period during 1 continuous admission. 23 overnight stays at CRU). You will not be able to leave the CRU during that time • 1 follow-up visit to the CRU about 7 days after the last dose •  1 follow-up phone call about 4 weeks after the last dose of study drug Your eligibility to take part in another study depends on information from this study. You may be eligible to receive a different study drug in another study as soon as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. The dose of the study drug that will be used to treat people COVID patients is not yet known. One group of up to 6 male participants will be in this part of the study. The dose level of study drug in this part cohort will be lower than the highest dose level already evaluated in healthy western participants in Part 1 and Part 2 of the study. Part 1 tested up to 750 mg with ritonavir. Part 2 tested up to 500 mg of study will be determined based on information from the previous dosing groupsdrug with 100 mg ritonavir 2 times a day. Dosing is planned as follows: DOSING GROUP NUMBER OF PARTICIPANTS STUDY DAYS -35 to -29 -28 to -22 -21 to -15 -14 to -8 -7 to -1 1 to 14 1 18 0.6 mg Saxenda 1.2 mg Saxenda 1.8 mg Saxenda 2.4 mg Saxenda 3 mg Saxenda 3 mg Saxenda + TBD* mg study drug or placebo *TBD – to be determined. Dosing for this part Group Number Number of the study will be based on data from the earlier dosing groups. It will be randomly assigned, like the flip of a coin, who receives either study drug or placebo You have about a 1 in 3 chance of being on placebo during the study. On study Day -35, you will visit the CRU for your first injection of Saxenda. It will be given to you by a qualified member of the study staff. Saxenda is given in the abdomen, upper thighs, or upper arms. You will be instructed on how to self-administer Saxenda at home during the 4 week run-in period. You will be given sufficient supplies for dosing at home and instructions about food and beverages relative to the timing of your once daily injections. You will also be instructed on how to store the medication. You will be given a dosing diary to record the dosing time of each dose given at home. You will return to the CRU every week during the outpatient run-in period (Participants Study Treatment Study Days -28, -21, and -14). You will bring your completed dosing diary with you at the time of these visits. During these visits, Saxenda will be administered by the CRU staff and you will be given sufficient supplies for dosing at home. On Ritonavir X X X X Study Day -7, you will be admitted to the CRU to continue Saxenda dosing -1: Single 100 mg dose of ritonavir given about 12 hours before beginning Day 1 morning dosing with study drug or placebo on and ritonavir Study Day 1. Saxenda doses while in the CRU will be given by the study staff, including Day -7 when you check in for the study. You will continue to receive a daily injection of Saxenda through Day -1 of the study. On Day -1 you will fast overnight for at least 10 hours before an OGTT. It will be done at about the same time as scheduled for Day 4. From Days 1 to 14, you will continue to receive Saxenda as a daily injection and you will also receive oral doses of study drug or placebo. On Days 1 – 3 and 5 - 14, you will fast overnight for at least 10 hours before receiving a standard breakfast. Breakfast will be provided about 30 minutes before dosing. It should be completely eaten within 20 minutes. Dosing will take place about 10 minutes after completing breakfast. Saxenda dosing will be within 5 minutes of study drug or placebo dosing. On Day 4, you will fast overnight for at least 10 hours before receiving a single oral : Single 300 mg dose of study drug or placebo. About 30 minutes after dosing, an OGTT will be done. The timing given with a single 100 mg dose of the OGTT may be changed based on the study drug blood levels from earlier ritonavir in the study. An OGTT involves drinking an 8 oz solution containing 75 grams morning; single 100 mg dose of sugar. It measures how well the body can break down sugar. A blood sample is taken before drinking the solution and approximately 4½ ritonavir given about 12 hours after. During this time period, blood samples will be collected approximately every 30 minutes. Both you and the study staff will not know whether you are receiving the study drug or placebo. In case after morning dosing Study Day 2: Single 100 mg dose of a medical emergency, the study investigator can find out what you have received if considered necessary. ritonavir given about 24 hours after morning dosing on Day 1 The doses of study drug and placebo that you receive may be compounded in our pharmacy for use in this part of the study. Compounded means that the ingredients are added together and mixed to make the final dose(s). All oral doses ritonavir will be taken with water. The total fluid volume of doses and water will be about 8 oz given orally (1cup)by mouth) as tablets. All doses of ritonavir and study drug will be given with about 8 oz. of water and must be completely swallowedswallowed whole. We will check your mouth after each dose of ritonavir and ritonavir with study drug to make sure the doses have been swallowed. Both you and the study staff will know which of the above you are receiving. On Day -1, you will be given a single dose of 100 mg of ritonavir in the evening, about 12 hours before morning dosing on Day 1. On Day 1 of the study, you will be given a single dose of 300 mg of study drug with 100 mg of ritonavir in the morning, after an overnight fast (nothing to eat or placebo have been swallowed drink except water) of at least 10 hours. You will receive a single 100 mg dose of ritonavir about 12 hours after the morning dose. On Day 2 of the study, you will receive a single dose of 100 mg of ritonavir about 24 hours after morning dosing on Day 1. This is a research study. The study drug and Saxenda drugs will be given to you only during this study and not after the study is over. Before any study procedures begin, you will be asked to read, sign, and date this consent document.

Number of Study Participants. There will be up to about 18 84 people joining taking part in this part of the studystudy if all dosing groups are done. You will be in this study for up to about 77 days30 days (Groups 1 – 5) or 34 days (Groups 6 and 7). This does not include the time between screening and dosing, which can be up to 28 days. This part of the study involves: • 1 outpatient run-in dosing period (with a single admission. The admission has 4 weeks) with 4 outpatient visits to overnight stays at the Clinical Research research Unit (CRU) • 1 for dosing period during 1 continuous admission. 23 groups 1–5, and 9 overnight stays at CRUfor dosing groups 6 and 7. You will not be able to leave the CRU during that time • 1 follow-up visit about 4 weeks after study drug dosing for female participants able to the CRU about 7 days after the last dose have children • 1 follow-up phone call about 4 weeks after the last dose study drug dosing for male participants and female participants unable to have children Your eligibility to take part in another study depends on information from this studyprevious studies. You may be eligible to receive a different study drug in another study as soon early as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. The dose of the study drug that will be used to treat people is not yet known. The dose known Up to 7 groups of study drug in this part of the study will be determined based on information from the previous dosing groupsparticipants are planned. Dosing is planned as follows: DOSING GROUP NUMBER OF PARTICIPANTS STUDY DAYS -35 to -29 -28 to -22 -21 to -15 -14 to -8 -7 to -1 DAY 1 to 1 14 1 18 0.6 A 3 14 C 5 14 E Study Treatment A: Single 100 mg Saxenda 1.2 dose (one 100 mg Saxenda 1.8 mg Saxenda 2.4 mg Saxenda 3 mg Saxenda 3 mg Saxenda + TBD* mg tablet) of immediate release (IR – study drug released quickly in the body) MST formulation under fasting conditions Study Treatment B: Single 100 mg dose (one 100 mg tablet) of the WG formulation under fasting conditions Study Treatment C: Single 300 mg dose (three 100 mg tablets) of the IR MST formulation under fasting conditions, if done Study Treatment D: Single 300 mg dose (three 100 mg tablets) of the WG formulation under fasting conditions, if done Study Treatment E: Single 100 mg dose (one 100 mg tablet) or placebo *TBD – 300 mg dose (three 100 mg tablets) under fed conditions, if done. Formulation to be determined. Dosing for this part of the study will be based on data from the earlier dosing groups. It will be randomly assigned, like the flip of a coin, who receives either study drug or placebo You have about a 1 in 3 chance of being on placebo during the study. On study Day -35, you will visit the CRU for your first injection of Saxenda. It will be given to you by a qualified member of the study staff. Saxenda is given in the abdomen, upper thighs, or upper arms. You will be instructed on how to self-administer Saxenda at home during the 4 week run-in period. You will be given sufficient supplies for dosing at home and instructions about food and beverages relative to the timing of your once daily injections. You will also be instructed on how to store the medication. You will be given a dosing diary to record the dosing time of each dose given at home. You will return to the CRU every week during the outpatient run-in period (Study Days -28, -21, and -14). You will bring your completed dosing diary with you at the time of these visits. During these visits, Saxenda will be administered by the CRU staff and you will be given sufficient supplies for dosing at home. On Study Day -7, you will be admitted to the CRU to continue Saxenda dosing before beginning dosing with study drug or placebo on Study Day 1. Saxenda doses while in the CRU will be given by the study staff, including Day -7 when you check in for the study. You will continue to receive a daily injection of Saxenda through Day -1 of the study. On Day -1 you will fast overnight for at least 10 hours before an OGTT. It will be done at about the same time as scheduled for Day 4. From Days 1 to 14, you will continue to receive Saxenda as a daily injection and you will also receive oral doses of study drug or placebo. On Days 1 – 3 and 5 - 14, you will fast overnight for at least 10 hours before receiving a standard breakfast. Breakfast will be provided about 30 minutes before dosing. It should be completely eaten within 20 minutes. Dosing will take place about 10 minutes after completing breakfast. Saxenda dosing will be within 5 minutes of study drug or placebo dosing. On Day 4, you will fast overnight for at least 10 hours before receiving a single oral dose of study drug or placebo. About 30 minutes after dosing, an OGTT will be done. The timing of the OGTT may be changed based on the study drug blood levels from earlier in the study. An OGTT involves drinking an 8 oz solution containing 75 grams of sugar. It measures how well the body can break down sugar. A blood sample is taken before drinking the solution and approximately 4½ hours after. During this time period, blood samples will be collected approximately every 30 minutes. Both you and the study staff will not know whether you are receiving the study drug or placebo. In case of a medical emergency, the study investigator can find out what you have received if considered necessary. The doses of study drug and placebo that you receive may be compounded in our pharmacy for use in this part of the study. Compounded means that the ingredients are added together and mixed to make the final dose(s). All oral doses will be taken with water. The total fluid volume of doses and water will be about 8 oz (1cup). All doses must be completely swallowed. We will check your mouth after each dose to make sure the study drug or placebo have been swallowed This is a research study. The study drug and Saxenda will be given to you only during this study and not after the study is over. Before any study procedures begin, you will be asked to read, sign, and date this consent document.