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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707990
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity and Overweight Drug: NNC0165-1875 Drug: Placebo (NNC0165-1875) Drug: Semaglutide Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : August 13, 2019
Actual Study Completion Date : August 13, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: NNC0165-1875
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
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.

Drug: Semaglutide
Participants will receive a single dose of s.c. semaglutide 0.25 mg injection.
Placebo Comparator: Placebo
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)
Participants will receive a single dose of s.c. placebo injection.

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


Outcome Measures
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Primary Outcome Measures :
  1. Number of treatment emergent adverse events (TEAEs) [ Time Frame: Day 1-36 ]
    Count of adverse events.


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707990


Locations
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United States, Arizona
Novo Nordisk Investigational Site
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03707990    
Other Study ID Numbers: NN9775-4398
U1111-1212-3615 ( Other Identifier: World Health Organization (WHO) )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com/sharing-results

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight