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

NCT03574584 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9747-4261U1111-1191-5147
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolism and Nutrition Disorders; Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  Count of adverse events.

  Week 0-25

Secondary Outcomes (2)

• 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)

• 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)

Study Arms (2)

NNC0165-1562 + Semaglutide

EXPERIMENTAL

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

Drug: NNC0165-1562; Drug: Semaglutide; Drug: Placebo (NNC0165-1562)

Placebo (NNC0165-1562) + Semaglutide

EXPERIMENTAL

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

Drug: NNC0165-1562; Drug: Semaglutide; Drug: Placebo (NNC0165-1562)

Interventions

NNC0165-1562 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.

NNC0165-1562 + Semaglutide; Placebo (NNC0165-1562) + Semaglutide

Semaglutide 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.

NNC0165-1562 + Semaglutide; Placebo (NNC0165-1562) + Semaglutide

Placebo (NNC0165-1562) DRUG

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

NNC0165-1562 + Semaglutide; Placebo (NNC0165-1562) + Semaglutide

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Novo Nordisk Investigational Site

Tempe, Arizona, 85283, United States

Location

Novo Nordisk Investigational Site

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Nutrition Disorders; Overweight; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 2, 2018
• Study Start: June 18, 2018
• Primary Completion: July 27, 2019
• Study Completion: July 27, 2019
• Last Updated: July 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)