A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese

Study Overview
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Brief Summary
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The study is looking at possible new medicines for weight control in people with high body weight. The study looks at how the new medicines work in the body. The study consists of two parts. If participants take part in Part 1, they will either get a single dose of NNC0165-1875 or a dummy medicine (placebo). If participants take part in Part 2, they will either get a single dose of NNC0165-1875 or dummy medicine and also a single dose of semaglutide. Which treatment participants get is decided by chance. For Part 1 participants will get 1 injection. For Part 2 participants will get 2 injections. A study nurse at the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The study will last for about 9 weeks. Participants will have 7 visits to the clinic with the study doctor.

Official Title
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A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0165-1875 as Monotherapy and in Combination With Semaglutide in Subjects With Overweight or Obesity

Conditions
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Obesity and Overweight

Intervention / Treatment
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* Drug: NNC0165-1875
* Drug: Placebo (NNC0165-1875)
* Drug: Semaglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males, aged 18-55 years (both inclusive) at the time of signing informed consent Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator Body weight greater than or equal to 70 kg Exclusion Criteria: - Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In total, 11 cohorts are planned. Five cohorts in Part 1 (cohort 1-5), and 6 cohorts (cohort 6-11) in Part 2. Each cohort will contain 8 participants. The first 2 participants will be randomised so one participant will receive active (Part 1: NNC0165-1875; Part 2: NNC0165-1875 and semaglutide) while the other receive placebo (Part 1: placebo; Part 2: placebo and semaglutide) treatment. The participants will remain in-house for a 5 days safety observation period. The remaining 6 subjects will be dosed at least after 96 hours.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC0165-1875<br>Participants will receive NNC0165-1875 alone in cohorts 1-5 (part 1) and NNC0165-1875 along with semaglutide in cohorts 6-11 (part 2). | Drug: NNC0165-1875<br>* Participants will receive a single dose of subcutaneous (s.c.) NNC0165-1875 injection. The planned doses of NNC0165-1875 are as following: cohort 1 and 7: 0.1 mg, cohort 2 and 8: 0.3 mg, cohort 3 and 9: 0.6 mg, cohort 4 and 10: 1.2 mg, cohort 5 and 11: 2.4 mg and cohort 6: 0.03 mg.<br>Drug: Semaglutide<br>* Participants will receive a single dose of s.c. semaglutide 0.25 mg injection.<br>|
| Placebo Comparator: Placebo<br>Participants will receive placebo alone in cohorts 1-5 (part 1) and placebo along with semaglutide in cohorts 6-11 (part 2). | Drug: Placebo (NNC0165-1875)<br>* Participants will receive a single dose of s.c. placebo injection.<br>Drug: Semaglutide<br>* Participants will receive a single dose of s.c. semaglutide 0.25 mg injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events (TEAEs) | Count of adverse events. | Day 1-36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞,1875,SD; the area under the NNC0165-1875 plasma concentration-time curve from time 0 to infinity after a single s.c. dose | Calculated based on plasma NNC0165-1875 measured (nmol*h/L) in blood. | 1-36 days | 
| Cmax,1875,SD; the maximum plasma concentration of NNC0165-1875 after a single s.c. dose | Calculated based on plasma NNC0165-1875 measured (nmol/L) in blood. | 1-36 days | 
| AUC0-∞,sema,SD; the area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single s.c. dose | Calculated based on plasma semaglutide measured (nmol*h/L) in blood. | 1-36 days | 
| Cmax,sema,SD; the maximum plasma concentration of semaglutide after a single s.c. dose | Calculated based on plasma semaglutide measured (nmol/L) in blood. | 1-36 days |