A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-18

Study Completion Date

2019-07-27

Brief Summary

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The study is investigating new medicines for weight control in people with high body weight. The study looks at how the study medicines work in the body. Participants will get semaglutide and either NNC0165-1562 or "dummy" medicine -which treatment participants get is decided by chance. Participants will get 2 injections per week for 5 months. A study nurse at the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The study will last for about 7 months. Participants will have 27 visits to the clinic.

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Detailed Description

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Conditions

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Metabolism and Nutrition Disorders Overweight or Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three (3) cohorts are planned. In each cohort subjects will be assigned to trial product. Subjects will be randomised in a 3:1 manner within cohorts to receive either:

1. Semaglutide and NNC0165-1562 once weekly (9 subjects per cohort)
2. Semaglutide and placebo once weekly (3 subjects per cohort)

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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NNC0165-1562 + Semaglutide

Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks.

Group Type EXPERIMENTAL

NNC0165-1562

Intervention Type DRUG

Participants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.

Semaglutide

Intervention Type DRUG

Participants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.

Placebo (NNC0165-1562)

Intervention Type DRUG

Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.

Placebo (NNC0165-1562) + Semaglutide

Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.

Group Type EXPERIMENTAL

NNC0165-1562

Intervention Type DRUG

Participants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.

Semaglutide

Intervention Type DRUG

Participants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.

Placebo (NNC0165-1562)

Intervention Type DRUG

Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.

Interventions

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NNC0165-1562

Participants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.

Intervention Type DRUG

Semaglutide

Participants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.

Intervention Type DRUG

Placebo (NNC0165-1562)

Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 19-55 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria

* Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and are not using highly effective contraceptive methods (Pearl Index less than 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or are pregnant, breast-feeding or intend to become pregnant.
* Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s), who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index less than 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No