A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese

NCT03707990 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9775-4398U1111-1212-3615
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The study is looking at possible new medicines for weight control in people with high body weight. The study looks at how the new medicines work in the body. The study consists of two parts. If participants take part in Part 1, they will either get a single dose of NNC0165-1875 or a "dummy" medicine (placebo). If participants take part in Part 2, they will either get a single dose of NNC0165-1875 or "dummy" medicine and also a single dose of semaglutide. Which treatment participants get is decided by chance. For Part 1 participants will get 1 injection. For Part 2 participants will get 2 injections. 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 9 weeks. Participants will have 7 visits to the clinic with the study doctor.

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  Count of adverse events.

  Day 1-36

Secondary Outcomes (4)

• AUC0-∞,1875,SD; the area under the NNC0165-1875 plasma concentration-time curve from time 0 to infinity after a single s.c. dose

  1-36 days

• Cmax,1875,SD; the maximum plasma concentration of NNC0165-1875 after a single s.c. dose

  1-36 days

• AUC0-∞,sema,SD; the area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single s.c. dose

  1-36 days

• Cmax,sema,SD; the maximum plasma concentration of semaglutide after a single s.c. dose

  1-36 days

Study Arms (2)

NNC0165-1875

EXPERIMENTAL

Participants will receive NNC0165-1875 alone in cohorts 1-5 (part 1) and NNC0165-1875 along with semaglutide in cohorts 6-11 (part 2).

Drug: NNC0165-1875; Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo alone in cohorts 1-5 (part 1) and placebo along with semaglutide in cohorts 6-11 (part 2).

Drug: Placebo (NNC0165-1875); Drug: Semaglutide

Interventions

NNC0165-1875 DRUG

Participants will receive a single dose of subcutaneous (s.c.) NNC0165-1875 injection. The planned doses of NNC0165-1875 are as following: cohort 1 and 7: 0.1 mg, cohort 2 and 8: 0.3 mg, cohort 3 and 9: 0.6 mg, cohort 4 and 10: 1.2 mg, cohort 5 and 11: 2.4 mg and cohort 6: 0.03 mg.

NNC0165-1875

Placebo (NNC0165-1875) DRUG

Participants will receive a single dose of s.c. placebo injection.

Placebo

Semaglutide DRUG

Participants will receive a single dose of s.c. semaglutide 0.25 mg injection.

NNC0165-1875; Placebo

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males, aged 18-55 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator
• Body weight greater than or equal to 70 kg

You may not qualify if:

• \- Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; 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: In total, 11 cohorts are planned. Five cohorts in Part 1 (cohort 1-5), and 6 cohorts (cohort 6-11) in Part 2. Each cohort will contain 8 participants. The first 2 participants will be randomised so one participant will receive active (Part 1: NNC0165-1875; Part 2: NNC0165-1875 and semaglutide) while the other receive placebo (Part 1: placebo; Part 2: placebo and semaglutide) treatment. The participants will remain in-house for a 5 days safety observation period. The remaining 6 subjects will be dosed at least after 96 hours.

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 16, 2018
• Study Start: October 15, 2018
• Primary Completion: August 13, 2019
• Study Completion: August 13, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)