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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03308721
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.6
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolism and Nutrition Disorder; Obesity	Drug: NNC9204-1177 A 1.0 mg/mL; Drug: PLACEBO	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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: A Multiple Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Multiple Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity
• Actual Study Start Date: Oct 16, 2017
• Actual Primary Completion Date: Jan 3, 2020
• Actual Study Completion Date: Jan 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC9204-1177 Dose trial with a sequential trial design	Drug: NNC9204-1177 A 1.0 mg/mL; 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.
Placebo Comparator: Placebo	Drug: PLACEBO; Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Number of treatment emergent adverse events (TEAEs) [Day 1-110]

   Count of events

Secondary Outcome Measures

1. The area under the NNC9204-1177 serum concentration-time curve at steady state [0-168 hours]

   Calculated based on NNC9204-1177 measured in blood.

2. The maximum serum concentration of NNC9204-1177 at steady state [Day 78-110]

   Calculated based on NNC9204-1177 measured in blood.

3. The time to maximum serum concentration of NNC9204-1177 [Day 78-110]

   Calculated based on NNC9204-1177 measured in blood.

4. The terminal half-life of NNC9204-1177 from steady state [Day 78-110]

   Calculated based on NNC9204-1177 measured in blood.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03308721
• Other Study ID Numbers: NN9277-4328; U1111-1189-1919
• First Posted: Oct 12, 2017
• Last Update Posted: Dec 23, 2021
• Last Verified: Dec 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 Dec 23, 2021