A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IV

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers Type 2 Diabetes

Treatments: Drug: Semaglutide B; Drug: Semaglutide N; Drug: Semaglutide L; Drug: Semaglutide J; Drug: Semaglutide M

Study type: Interventional

Funder types: Industry

Identifiers

NCT06642584

NN9501-5006

U1111-1304-9627 (Other Identifier)

Details and patient eligibility

About

This study is conducted to compare four different tablets containing the investigational medicine semaglutide at the same dose. It is done to test how semaglutide in each of the tablet versions is taken up in the body. Which treatments participants will receive is decided by chance. The study will last for about 28 weeks. The study will enroll healthy male participants.

Enrollment: 90 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male.
2. Age 18-64 years (both inclusive) at the time of signing the informed consent.
3. Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
4. Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

1. Known or suspected hypersensitivity to study interventions or related products.
2. Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
3. Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days prior to first dosing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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90 participants in 6 patient groups

Sequence 1: Semaglutide J then Semaglutide L

Experimental group

Description:

Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2.

Treatment:

Drug: Semaglutide J

Drug: Semaglutide L

Drug: Semaglutide B

Sequence 2: Semaglutide L then Semaglutide J

Experimental group

Description:

Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2.

Treatment:

Drug: Semaglutide J

Drug: Semaglutide L

Drug: Semaglutide B

Sequence 3: Semaglutide J then Semaglutide M

Experimental group

Description:

Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2.

Treatment:

Drug: Semaglutide M

Drug: Semaglutide J

Drug: Semaglutide B

Sequence 4: Semaglutide M then Semaglutide J

Experimental group

Description:

Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2.

Treatment:

Drug: Semaglutide M

Drug: Semaglutide J

Drug: Semaglutide B

Sequence 5: Semaglutide J then Semaglutide N

Experimental group

Description:

Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2.

Treatment:

Drug: Semaglutide J

Drug: Semaglutide N

Drug: Semaglutide B

Sequence 6: Semaglutide N then Semaglutide J

Experimental group

Description:

Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then semaglutide J in treatment period 2.

Treatment:

Drug: Semaglutide J

Drug: Semaglutide N

Drug: Semaglutide B