A Research Study of a New Medicine NNC0519-0130 in Healthy People, People With High Body Weight and People With Type 2 Diabetes.

• Status: Recruiting
• Trial end date: 2023-04-27
• Target enrollment: 0
• Participant gender: All

Summary

NNC0519-0130 is a study medicine with the potential to improve metabolism of fat and sugar and fat in the body of patients with diabetes and to lower the body weight in people who are overweight. The safety and tolerability of the new medicine NNC0519-0130 and its concentrations in the blood will be looked for in this study. Moreover, effects on blood sugar, fat metabolism and body weight will be tested. There will be different study parts with different participants. Healthy participants (men) with high body weight and people with diabetes (men and women) will take part. Single doses and multiple doses will be tested and the medicine will be studied as an injection or will be given orally (as a tablet). The treatment participants get is decided by chance. Single ascending dose (SAD) part: In the first part of the study; the effects of single injected doses of NNC0519-0130 will be examined. Participants will either get one dose of the new medicine NC0519-0130 or one dose of placebo that does not contain active medicine. The injection will be given by trained staff into the tissue underneath the skin of belly. The study will last between 3 ½ weeks up to a approximately 7 weeks (up to 11 weeks in case of rescheduling). Participants will have 9 visits with the study doctor, including one 6-day inhouse stay (5 nights). Multiple ascending dose (MAD) subcutaneous part: In this part of the study; the effects of daily injected doses of NNC0519-0130 taken over the course of several weeks will be examined. Participants will take the study medicine once daily and that the dose is increased every three weeks, if safety and tolerability allow. Participants will take up to five different dose levels. The period with daily injections of study medicine will in total last up to 15 weeks. Participants will either get the study medicine NNC0519-0130 or placebo (a 'dummy' medicine that looks like the medicines but without any active medicine). Participants will have up to six in-house stays (of 4 to 7 days each), and up to 15 outpatient visits and up to 35 telephone visits. The total duration of the study could last up to 27 weeks. MAD Oral part: In this part of the study; the effects of daily oral doses of NNC0519-0130 taken as tablets over the course of several weeks will be examined. Participants take the study medicine once daily and that the dose is increased every three weeks, if safety and tolerability allow. Participants will take up to four different dose levels. Total period with daily intake of the study medicine will last 12 weeks. Participants will either get the study medicine NNC0519-0130 or placebo (a 'dummy' medicine that looks like the medicines but without any active medicine). Participants will have up to 5 in-house stays (4 to 5 days each), and up to13 outpatient visits and up to 28 telephone visits. The total duration of the study could last up to 24 weeks. Type 2 diabetes (T2D) part: In this part of the study; the effects in patients with type 2 diabetes who take once daily injected doses of NNC0519-0130 over a course of 4 weeks will be examined. Treatment starts with a relatively low dose which is increased after 1 week and 2 weeks of treatment and the target dose will then be taken during the last 2 weeks of treatment. Participants will either be treated with the study medicine NNC0519-0130 or with placebo (a 'dummy' medicine that looks like the medicines but without any active medicine). Participants will have 4 in-house stays (4 to 5 days each), 6 outpatient visits and 12 telephone visits. The total duration of the study could last up to 16 weeks.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Single ascending dose (SAD) part:

• Male aged 18-55 years (both inclusive) at screening

• Body mass index between 18.5 kilogram per meter square (kg/m^2) and 27.0 kg/m^2 (both inclusive) at screening

• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

• Multiple ascending dose (MAD) part:

• Male aged 18-55 years (both inclusive) at screening

• Body mass index between 25.0 kg/m^2 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator

• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

• Type 2 diabetes (T2D) part:

• Female of non-childbearing potential or male aged 18-64 years (both inclusive) at screening

• Body mass index between 25.0 kg/m^2 and 39.9 kg/m^2 (both inclusive) at screening

• Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening

• Treatment naive to antidiabetic drugs or on a stable daily dose(s) metformin therapy (any metformin formulation) within 90 days before screening. The metformin dose should be greater than or equal to (≥) 1000 milligrams (mg) to less than or equal to (≤) 3000 mg or maximum tolerated or effective dose documented in participant's medical record or per investigator discretion

• Insulin naive. However, short-term insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes

• HbA1c in the range of 6.5% (inclusive) and 9.5% (inclusive)

Exclusion Criteria:

• Single ascending dose (SAD) part:

• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

• Glycosylated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening

• Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening

• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions

• HbA1c greater than or equal to (≥) 6.5 % (48 mmol/mol) at screening

• Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening

• Multiple ascending dose (MAD) part:

• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions

• HbA1c greater than or equal to (≥) 6.5 % (48 mmol/mol) at screening

• Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening

• Type 2 diabetes (T2D) part:

• Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus)

• Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, growth hormone, non-routine vitamins or herbal products

• Current treatment with selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants