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Completed

NCT Number: NCT03707990

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

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.

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Key information

Conditions

Obesity and Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NNC0165-1875

Drug

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.

Placebo (NNC0165-1875)

Drug

Participants will receive a single dose of s.c. placebo injection.

semaglutide

Drug

Participants will receive a single dose of s.c. semaglutide 0.25 mg injection.

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: Day 1-36

    Count of adverse events.

Secondary outcomes

  1. AUC0-∞,1875,SD; the area under the NNC0165-1875 plasma concentration-time curve from time 0 to infinity after a single s.c. dose

    Time frame: 1-36 days

    Calculated based on plasma NNC0165-1875 measured (nmol*h/L) in blood.

  2. Cmax,1875,SD; the maximum plasma concentration of NNC0165-1875 after a single s.c. dose

    Time frame: 1-36 days

    Calculated based on plasma NNC0165-1875 measured (nmol/L) in blood.

  3. AUC0-∞,sema,SD; the area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single s.c. dose

    Time frame: 1-36 days

    Calculated based on plasma semaglutide measured (nmol*h/L) in blood.

  4. Cmax,sema,SD; the maximum plasma concentration of semaglutide after a single s.c. dose

    Time frame: 1-36 days

    Calculated based on plasma semaglutide measured (nmol/L) in blood.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2018
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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