Clinical trial NCT03574584: A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese
Official title: An Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Multiple Weekly Doses of NNC0165-1562 and Semaglutide in Subjects With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorders
Overweight or Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-07-02
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: Week 0-25
Secondary outcomes:
measure: AUC0-168h,1562,SS; the area under the NNC0165-1562 plasma concentration-time curve from time 0 to 168 hours at steady state
timeFrame: Week 19 (day 134) to week 20 (day 141)
measure: AUC0-168h,sema,SS; the area under the semaglutide plasma concentration time curve from 0 to 168 hours at steady state
timeFrame: Week 19 (day 134) to week 20 (day 141)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Lincoln
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: