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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: NNC0487-0111 A; Drug: NNC0487-0111 C; Drug: Acetaminophen - 500 mg/15 ml; Drug: Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06461039

U1111-1300-3685 (Other Identifier)

NN9487-7612

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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43 participants in 1 patient group

NNC0487-0111

Experimental group

Description:

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.

Treatment:

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

Drug: Acetaminophen - 500 mg/15 ml

Drug: NNC0487-0111 C

Drug: NNC0487-0111 A