Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity

NCT03308721 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9277-4328U1111-1189-1919
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at a new study medicine for weight management in people with overweight or obesity. The aim of this study is to find out how safe and tolerable the study medicine is. The study also looks at how the study medicine behaves in the body and how it is removed from the body. Participants will either get NNC9204-1177 (the new study medicine) or placebo (a formula that looks like the study medicine but does not have active ingredients). Which treatment participants get will be decided by chance. NNC9204-1177 has not been approved by the United States Food and Drug Administration. Its use in this study is experimental. Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks. The study will last for about 5 months. Participants will have 19 clinic visits with the study doctor. At certain times during the study, participants will have blood draws and 3 different kinds of electrocardiograms. Participants will answer mental health questionnaires. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Conditions

Metabolism and Nutrition Disorder; Obesity

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  Count of events

  Day 1-110

Secondary Outcomes (4)

• The area under the NNC9204-1177 serum concentration-time curve at steady state

  0-168 hours

• The maximum serum concentration of NNC9204-1177 at steady state

  Day 78-110

• The time to maximum serum concentration of NNC9204-1177

  Day 78-110

• The terminal half-life of NNC9204-1177 from steady state

  Day 78-110

Study Arms (2)

NNC9204-1177

EXPERIMENTAL

Dose trial with a sequential trial design

Drug: NNC9204-1177 A 1.0 mg/mL

Placebo

PLACEBO COMPARATOR

Drug: PLACEBO

Interventions

NNC9204-1177 A 1.0 mg/mL DRUG

Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks. Dose gradually increased to 6000 μg.

NNC9204-1177

PLACEBO DRUG

Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 27.0 and 39.9 kg/m2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator

You may not qualify if:

• Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
• Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk greater than or equal to 5%
• Male subjects who are not sexually abstinent or 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 below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), or who intend to donate sperm in the period from screening until 3 months following last administration of the investigational medical product
• 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 who are not using highly effective contraceptive methods (Pearl Index below 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 who are pregnant, breast-feeding or intend to become pregnant

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Overland Park, Kansas, 66212, United States

Location

Related Publications (1)

• Skovgaard D, Haahr PM, Lester R, Clark K, Paglialunga S, Finer N, Friedrichsen MH, Hjerpsted JB, Engelmann MDM. Prevalence of Baseline Cardiac Arrhythmias in Participants with Overweight or Obesity in Phase 1 Clinical Trials: Analysis of 24-Hour Holter Electrocardiogram Recordings. J Clin Pharmacol. 2023 May;63(5):539-543. doi: 10.1002/jcph.2193. Epub 2023 Jan 20.

  PMID: 36524539 DERIVED

MeSH Terms

Conditions

Nutrition Disorders; Obesity

Condition Hierarchy (Ancestors)

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

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

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 12, 2017
• Study Start: October 16, 2017
• Primary Completion: January 3, 2020
• Study Completion: January 3, 2020
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)