A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-14

Study Completion Date

2025-04-04

Brief Summary

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This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. The study medicine will taken orally for 18 weeks and then study medicine will be injected with a thin needle in a skin fold in the abdomen for 9 weeks.The study will last for about 35 weeks.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NNC0487-0111

Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4.

Group Type EXPERIMENTAL

NNC0487-0111 A

Intervention Type DRUG

NNC0487-0111 A will be administered subcutaneously.

NNC0487-0111 C

Intervention Type DRUG

NNC0487-0111 C will be taken orally.

Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)

Intervention Type DRUG

Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally.

Acetaminophen - 500 mg/15 ml

Intervention Type DRUG

Acetaminophen - 500 mg/15 ml will be taken orally.

Interventions

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NNC0487-0111 A

NNC0487-0111 A will be administered subcutaneously.

Intervention Type DRUG

NNC0487-0111 C

NNC0487-0111 C will be taken orally.

Intervention Type DRUG

Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)

Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally.

Intervention Type DRUG

Acetaminophen - 500 mg/15 ml

Acetaminophen - 500 mg/15 ml will be taken orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females of non-childbearing potential.
* Age 18 - 65 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 25.0 and 39.9 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.

Exclusion Criteria

* Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Any contraindications for the use of the oral contraception used in the study according to the Microgynon Product Information.
* Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic CYP pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening.

Exceptions are routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.

* History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No