NNC0638-0355 for Obesity

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Novo Nordisk A/S

Disqualifiers: Diabetes, Vitamin D deficiency, others

Trial Summary

What is the purpose of this trial?

The study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in your body, and what your body does to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What makes the drug NNC0638-0355 unique for treating obesity?

The drug NNC0638-0355 is unique because it may target novel pathways or mechanisms not addressed by existing obesity treatments, which often focus on appetite suppression or fat absorption. While specific details about NNC0638-0355 are not provided, it could potentially offer a new approach compared to current drugs like orlistat, which inhibits fat absorption, or lorcaserin, which affects serotonin receptors to reduce appetite. ^{1 2 3 4 5}

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

This trial is for people who are living with overweight or obesity. Participants will be chosen randomly to receive either the new medicine NNC0638-0355 or a placebo, both administered as injections under the skin.

Inclusion Criteria

I am either male or female.

My BMI is between 25.0 and 34.9, and I am considered overweight due to excess fat.

Considered to be generally healthy 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

Total calcium outside normal range at screening

Known or suspected hypersensitivity to study intervention(s) or related products

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single ascending dose (SAD) of either NNC0638-0355 or placebo

6 weeks

Treatment Part B, C, D

Participants receive multiple ascending doses (MAD) of either NNC0638-0355 or placebo

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NNC0638-0355 (Other)

Trial Overview The study is evaluating NNC0638-0355, a potential new medication that cannot yet be prescribed by doctors. It aims to determine its safety and how it affects and is processed by the body of individuals with overweight or obesity.

Participant Groups

Group I: NNC0638-0355 Experimental Treatment 1 Intervention

Participants will be randomized to receive NNC0638-0355. The study will be conducted in 4 parts. Part A: Single ascending dose (SAD) Part B, C and D: Multiple ascending dose (MAD).

Group II: Placebo Placebo Group 1 Intervention

Participants will be randomized to receive Placebo. The study will be conducted in 4 parts. Part A: Single ascending dose (SAD). Part B,C and D: Multiple ascending dose (MAD).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

ICON San Antonio, TX

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Findings from Research

Lorcaserin and the combination of Phentermine-topiramate (phen-top) are two FDA-approved drugs for obesity, with lorcaserin showing moderate efficacy and an acceptable safety profile, while phen-top has shown reasonable efficacy but carries risks like teratogenicity and psychiatric issues.

Cetilistat, currently in phase 3 trials, is a lipase inhibitor that may offer a better safety profile than orlistat, and other promising anti-obesity drugs targeting the gut, such as exenatide and liraglutide, are also under investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New and emerging drug molecules against obesity. George, M., Rajaram, M., Shanmugam, E.[2014]

Obesity is a major health issue that requires effective interventions, and pharmacotherapy is increasingly necessary alongside diet and behavioral changes for many individuals.

New drug candidates targeting the hypothalamic regulation of food intake have shown promising efficacy, particularly fixed-dose combinations that outperform current antiobesity therapies, with a stronger focus on safety and tolerability in their development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of late-stage CNS drug candidates for the treatment of obesity. Heal, DJ., Gosden, J., Smith, SL.[2016]

The conference highlighted various innovative approaches to developing safe and effective obesity drugs, focusing on different neuroendocrine and peripheral tissue targets, which is crucial given the global obesity epidemic.

Key agents discussed included rimonabant, which has completed extensive phase III trials, and early-stage drugs like selective 5-HT(2C) agonists and synthetic analogs of gut hormones, indicating a diverse pipeline of potential treatments for obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity Drug Development Summit. 21-22 July, 2005, Arlington, VA, USA. Maggio, CA.[2007]

A new series of spirocyclic compounds were developed as antagonists for the NPY Y5 receptor, showing very strong binding affinity (K(i) values ≤ 1 nM) in laboratory tests.

Despite the strong binding and good stability of compound 7a, it did not lead to weight loss in a rat model of obesity, indicating that high brain levels of the drug did not translate to effective weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovery and evaluation of spirocyclic derivatives as antagonists of the neuropeptide Y5 receptor. Fichtner, M., Lee, E., Tomlinson, E., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

New and emerging drug molecules against obesity. [2014]

2. Italy pubmed.ncbi.nlm.nih.gov

Design, in silico study, synthesis and in vitro evaluation of some N5-(1H-pyrazol-3-yl)-3H-benzo[d]imidazole-2,5-diamine derivatives as potential pancreatic lipase inhibitors for anti-obesity activity. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A review of late-stage CNS drug candidates for the treatment of obesity. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Obesity Drug Development Summit. 21-22 July, 2005, Arlington, VA, USA. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Discovery and evaluation of spirocyclic derivatives as antagonists of the neuropeptide Y5 receptor. [2019]