Brief Title For this Study 123

Study identifier:Test05082024

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

Test05082024 A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese but otherwise Healthy Subjects.

Medical condition

AZ_UAT_PVS_05082024, obesity

Phase

Phase 2

Healthy volunteers

yes

Study drug

NNC0165-1562, placebo

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 years - 55 years

Date

Study Start Date: 05 Aug 2024

Estimated Primary Completion Date: 05 Aug 2024

Estimated Study Completion Date: 05 Aug 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by Intrasphere

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Part I (SD):
- Male, 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). Overweight should be due to excess of adipose tissue, as judged by the investigator
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
- Part II (MD):
- 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). Overweight should be due to excess of adipose tissue, as judged by the investigator
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria

- Any clinically significant weight change (at least 5% self-reported change during the previous 3 months), dieting attempts (e.g. participation in an organised weight reduction programme within the last 3 months), prior obesity surgery, or medications affecting body weight within 3 months prior to screening
- Male subjects who are not 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 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following 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 are not using highly effective contraceptive methods (Pearl Index 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), and/or are pregnant, breast-feeding or intend to become pregnant) (applicable to Part II (MD) only)

No locations available

Arms	Assigned Interventions
Experimental: NNC0165-1562	Drug: NNC0165-1562 Administered subcutaneously (s.c., under the skin) single dose [SD] or multiple dose [MD] with daily dosing.
Placebo Comparator: Placebo	Drug: placebo Administered subcutaneously (s.c., under the skin) single dose [SD]) or multiple dose [MD] with daily dosing.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

null Novo Nordisk

[email protected]

Investigators

Principal Investigator

Global Clinical Registry (GCR, 1452)

Novo Nordisk A/S