A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or Obesity

NCT04010786 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9215-4424U1111-1226-5167
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at NNC0247-0829 (a potential new medicine) for weight management in people with overweight or obesity. The study looks at how NNC0247-0829 works in the body. Participants will either get NNC0247-0829 or placebo (a 'dummy' medicine) - which treatment is decided by chance. NNC0247-0829 is an experimental medicine which has not been approved by the US FDA. Participants will get either 1 injection or a total of 4 injections (one week apart) by a study nurse at the clinic depending on what group they are in. The study will last for about 18 months, but participation will last from 11 to 23 weeks. This will depend on the group participants are in. Participants will attend 8 to 14 visits at the clinic with the study staff. Some participants will have one 16-day, 15-night visit and one 2-day, 1-night visit. Others will have two 2-day, 1-night visits. At all visits except one, participants will have blood tests and other checks. They will be asked about their health, medical history and habits including mental health questionnaires.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs)

  Number of events

  From time of first dosing (Day 1) until Day 71

• For multiple dose (MD) cohorts: Number of treatment emergent adverse events (TEAEs)

  Number of events

  From time of first dosing (Day 1) until Day 85

Secondary Outcomes (5)

• For SD cohorts: Number of injection site reactions

  From time of first dosing (Day 1) until Day 71

• For SD cohorts: Occurrence of anti-NNC0247-0829 antibodies

  From time of first dosing (Day 1) until Day 71

• For MD cohorts: Number of injection site reactions

  From time of first dosing (Day 1) until Day 85

• For MD cohorts: Occurrence of anti-NNC0247-0829 antibodies

  From time of first dosing (Day 1) until Day 85

• For (SD) cohorts: The area under the NNC0247-0829 serum concentration-time curve from time 0 to infinity

  From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (from Day 71 up to Day 134, depending on the dose cohort)

Study Arms (2)

Active treatment NNC0247-0829

EXPERIMENTAL

Up to 6 single dose cohorts are planned with 10 subjects in each; 8 will receive active treatment. Up to 2 multiple dose cohorts are planned with 12 subjects in each; 8 will receive active treatment

Drug: NNC0247-0829

Placebo

PLACEBO COMPARATOR

In each of the 6 single dose cohorts, 2 subjects will receive placebo. In the 2 multiple dose cohorts, 4 subjects will receive placebo

Drug: Placebo (NNC0247-0829)

Interventions

NNC0247-0829 DRUG

Participants will receive either single or multiple doses given subcutaneously (s.c., under the skin) in a lifted fold of the stomach skin. Dose level and number of doses will depend on the cohort.

Active treatment NNC0247-0829

Placebo (NNC0247-0829) DRUG

Participants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female not of childbearing potential (CBP) or male, aged 18-60 years (both inclusive) at the time of signing informed consent.
• Body mass index (BMI) between 27.0 and 34.9 kg/m\^2 (both inclusive) in the SD cohorts and between 27.0 and 39.9 kg/m\^2 (both inclusive) in the MD cohorts at screening. Overweight or obesity should be due to excess adipose tissue, as judged by the investigator.

You may not qualify if:

• Male subject who is not surgically sterilised (vasectomised) and is sexually active with female partner of childbearing potential in the absence of highly effective contraception.
• Any disorder, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
• Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Mild painkillers are permitted until 24h prior to screening.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

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: First human dose trial; a single-centre, placebo-controlled, double-blind (within cohorts), randomised SD and MD ascending dose trial with a sequential trial design

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 8, 2019
• Study Start: July 11, 2019
• Primary Completion: June 11, 2022
• Study Completion: June 21, 2022
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)