A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg; Drug: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg; Drug: Semaglutide 2.4 mg and placebo 2.0 mg; Drug: Semaglutide 2.4 mg and placebo 1.0 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04969939

U1111-1254-9046 (Other Identifier)

NN9775-4708

Details and patient eligibility

About

The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• Male or female, age above or equal to 18 years at the time of signing informed consent.
• BMI 30.0-45.0 kg/m^2 (both inclusive) at the screening visit.

Exclusion criteria

• HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening.

  • History of type 1 or type 2 diabetes mellitus.
  • Treatment with glucose-lowering agent(s) within 90 days before screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

Semaglutide 2.4 mg and NNC0165-1875 2.0 mg

Experimental group

Description:

Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg

Treatment:

Drug: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg

Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg)

Placebo Comparator group

Description:

Participants will receive placebo as an add on to semaglutide 2.4 mg.

Treatment:

Drug: Semaglutide 2.4 mg and placebo 2.0 mg

Semaglutide 2.4 mg and NNC0165-1875 1.0 mg

Experimental group

Description:

Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg

Treatment:

Drug: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg

Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg)

Placebo Comparator group

Description:

Participants will receive placebo as an add on to semaglutide 2.4 mg.

Treatment:

Drug: Semaglutide 2.4 mg and placebo 1.0 mg