A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Type 2 Diabetes

Treatments: Drug: Semaglutide Dose 4; Drug: Semaglutide D Dose 1; Drug: Semaglutide Dose 6; Drug: Semaglutide Dose 5; Drug: Semaglutide D Dose 3; Drug: Semaglutide D Dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT05227196

NN9924-4799

Details and patient eligibility

About

The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in.

The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks.

The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).

Enrollment: 546 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 21.0 and 32.0 kg/m^2 (both inclusive).
• 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

• HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening.

• Use of tobacco and nicotine products, defined as any of the below:

• Smoking more than 5 cigarettes or the equivalent per day

• Not willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods

• Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

• History(a) 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(a).

• Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma(a).

  1. As declared by the participant or reported in the medical records

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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546 participants in 6 patient groups

Group 1 Sequence 1

Experimental group

Description:

Crossover arm

Treatment:

Drug: Semaglutide D Dose 3

Drug: Semaglutide D Dose 2

Drug: Semaglutide Dose 6

Drug: Semaglutide D Dose 1

Group 1 Sequence 2

Experimental group

Description:

Crossover arm

Treatment:

Drug: Semaglutide D Dose 3

Drug: Semaglutide Dose 5

Drug: Semaglutide Dose 6

Drug: Semaglutide Dose 4

Group 2 Sequence 1

Experimental group

Description:

Crossover arm

Treatment:

Drug: Semaglutide D Dose 2

Drug: Semaglutide Dose 5

Drug: Semaglutide D Dose 1

Drug: Semaglutide Dose 4

Group 2 Sequence 2

Experimental group

Description:

Crossover arm

Treatment:

Drug: Semaglutide D Dose 2

Drug: Semaglutide Dose 5

Drug: Semaglutide D Dose 1

Drug: Semaglutide Dose 4

Group 3 Sequence 1

Experimental group

Description:

Crossover arm

Treatment:

Drug: Semaglutide D Dose 1

Drug: Semaglutide Dose 4

Group 3 Sequence 2

Experimental group

Description:

Crossover arm

Treatment:

Drug: Semaglutide D Dose 1

Drug: Semaglutide Dose 4