A Research Study to See How a New Medicine (NNC0487-0111) Works in People With Overweight or Obesity When Injected Under the Skin

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06064006
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.5
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under the skin

Condition or Disease	Intervention/Treatment	Phase
Obesity; Overweight	Drug: NNC0487-0111; Drug: Placebo (NNC0487-0111)	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 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 Randomised, Placebo-controlled and Double-blinded Study Assessing the Safety, Tolerability and Pharmacokinetics of Subcutaneous Administrations of NNC0487-0111 in Participants With Overweight or Obesity
• Actual Study Start Date: Sep 15, 2023
• Anticipated Primary Completion Date: Oct 31, 2024
• Anticipated Study Completion Date: Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC0487-0111 Participants will be randomized to receive NNC0487-0111. The study will be conducted in 3 parts. Part A: Single ascending dose (SAD) Part B and C: Multiple ascending dose (MAD)	Drug: NNC0487-0111; NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.; Drug: Placebo (NNC0487-0111); Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.
Placebo Comparator: Placebo Participants will be randomized to receive Placebo. The study will be conducted in 3 parts. Part A: Single ascending dose (SAD). Part B and C: Multiple ascending dose (MAD).	Drug: NNC0487-0111; NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.; Drug: Placebo (NNC0487-0111); Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection.

Outcome Measures

Primary Outcome Measures

1. PART A: Number of treatment emergent adverse events (TEAE) [From pre-dose on Day 1 until completion of the end of study visit, up to 24 days]

   Number of events

2. Parts B and C: Number of treatment emergent adverse events (TEAE) [From pre-dose on Day 1 until completion of the end of study visit, up to 35 weeks]

   Number of events

Secondary Outcome Measures

1. PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose [From pre-dose on Day 1 until completion of the end of study visit, up to 24 days]

   h*nmol/L

2. PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax [From pre-dose on Day 1 until completion of the end of study visit, up to 24 days]

   nmol/L

3. Parts B and C: The area under the NNC0487-0111 plasma concentration-time curve. [From pre-dose on V33 Day1 until V34, up to 9 days]

   h*nmol/L

4. Parts B and C: Cmax,SS; the maximum plasma concentration of NNC0487 0111 after last multiple dose and the corresponding time tmax [From pre-dose on V33 Day 1 until end of study visit, up to 23 days]

   nmol/L

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/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

• HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening

• Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:

• Vitamin D (25-hydroxycholecalciferol) below 12 ng/mL (30 nM) at screening

• Parathyroid hormone (PTH) outside normal range at screening

• Total calcium outside normal range at screening

• Amylase equal to or greater than 2 times upper limit of normal at screening

• Lipase equal to or greater than 2 times upper limit of normal at screening

• Calcitonin equal to or greater than 50 ng/L at screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78209

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT06064006
• Other Study ID Numbers: NN9490-7613; U1111-1289-3282
• First Posted: Oct 3, 2023
• Last Update Posted: Oct 3, 2023
• Last Verified: Sep 1, 2023

• 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; Overweight

Study Results

No Results Posted as of Oct 3, 2023