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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03574584
• Collaborator: (none)
• Enrollment: 37
• Locations: 2
• Arms: 2
• Actual Duration (Months): 13.3
• Patients Per Site: 18.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolism and Nutrition Disorders; Overweight or Obesity	Drug: NNC0165-1562; Drug: Semaglutide; Drug: Placebo (NNC0165-1562)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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: Semaglutide and NNC0165-1562 once weekly (9 subjects per cohort) Semaglutide and placebo once weekly (3 subjects per cohort)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:Semaglutide and NNC0165-1562 once weekly (9 subjects per cohort) Semaglutide and placebo once weekly (3 subjects per cohort)
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 18, 2018
• Actual Primary Completion Date: Jul 27, 2019
• Actual Study Completion Date: Jul 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC0165-1562 + Semaglutide Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks.	Drug: 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.; 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.; Drug: Placebo (NNC0165-1562); Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.
Experimental: Placebo (NNC0165-1562) + Semaglutide Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.	Drug: 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.; 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.; Drug: Placebo (NNC0165-1562); Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.

Outcome Measures

Primary Outcome Measures

1. Number of treatment emergent adverse events (TEAEs) [Week 0-25]

   Count of adverse events.

Secondary Outcome Measures

1. AUC0-168h,1562,SS; the area under the NNC0165-1562 plasma concentration-time curve from time 0 to 168 hours at steady state [Week 19 (day 134) to week 20 (day 141)]

   Measured in nmol*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134.

2. AUC0-168h,sema,SS; the area under the semaglutide plasma concentration time curve from 0 to 168 hours at steady state [Week 19 (day 134) to week 20 (day 141)]

   Measured in nmol*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Tempe	Arizona	United States	85283
2	Novo Nordisk Investigational Site	Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03574584
• Other Study ID Numbers: NN9747-4261; U1111-1191-5147
• First Posted: Jul 2, 2018
• Last Update Posted: Jul 2, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Nutrition Disorders; Overweight

Study Results

No Results Posted as of Jul 2, 2021