Research Study to Investigate the Effect of NNC0174-0833 on a Birth Control Pill in Women Who Are Not Able to Become Pregnant

NCT ID: NCT04074174

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-12
• Study Completion Date: 2020-03-06

Brief Summary

The study looks at how the study medicine affects the level in the blood of a birth control pill. The study also looks at how the study medicine affects the duration of emptying of the stomach. Participants will get 1 injection of study medicine once a week for 12 weeks by a study nurse at the clinic. The study medicine is injected with a thin needle in a skin fold in the stomach. In addition, participants will get 1 birth control pill per day for 8 days before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Participants will also get a dose of acetaminophen before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Acetaminophen is a mild painkiller but used here to assess the emptying of the stomach. The study will last for about 9 months, but participants will only be in the study for about 6 months. Participants will have 17 clinic visits with the study staff and some will be overnight visits. There will also be 3 phone calls with the study staff. At all visits, participants will have blood drawn along with other clinical assessments. Participants will be asked about their health, diseases and habits including mental health questionnaires. Participants must not be able to become pregnant if they want to participate in the study.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NNC0174-0833 treatment-free period; NNC0174-0833 treatment

During the NNC0174-0833 treatment-free period participants will receive OC tablets and acetaminophen. During the NNC0174-0833 treatment period participants will receive OC tablets and acetaminophen in addition to NNC0174-0833.

Group Type: EXPERIMENTAL

NNC0174-0833

Intervention Type: DRUG

NNC0174-0833 administered s.c. (subcutaneously, under the skin) once weekly for 12 weeks

Oral contraceptive (OC) tablets

Intervention Type: DRUG

1 tablet daily on days 1-8 and days 79-86

Acetaminophen

Intervention Type: DRUG

Single dose of acetaminophen as part of a standardised meal on day 1 and day 79

Interventions

NNC0174-0833

NNC0174-0833 administered s.c. (subcutaneously, under the skin) once weekly for 12 weeks

Intervention Type: DRUG

Oral contraceptive (OC) tablets

1 tablet daily on days 1-8 and days 79-86

Intervention Type: DRUG

Acetaminophen

Single dose of acetaminophen as part of a standardised meal on day 1 and day 79

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female of non-childbearing potential, aged 18-65 years (both inclusive) at the time of signing informed consent.
• Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria

• Known or suspected hypersensitivity to trial products (including acetaminophen) or related products.
• Previous participation in this trial. Participation is defined as signed informed consent.
• Previous participation in trial(s) with NNC0174-0833 unless documented that the subject was assigned to placebo treatment. Participation is defined as randomised.
• Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

U1111-1228-4219

Identifier Type: OTHER

Identifier Source: secondary_id

NN9838-4517

Identifier Type: -

Identifier Source: org_study_id