NNC0638-0355 for Obesity

Overseen By Novo Nordisk

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Disqualifiers: Diabetes, Vitamin D deficiency, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, NNC0638-0355, for individuals with overweight or obesity to assess its safety and understand its effects in the body. Participants will receive either the study medicine or a placebo, which resembles the medicine but lacks the active ingredient. The trial includes different stages to evaluate various doses. Suitable candidates have a BMI (a measure of body fat based on height and weight) between 25 and 34.9 and are generally healthy. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that NNC0638-0355 is likely to be safe for humans?

Research shows that NNC0638-0355 remains in the early stages of testing for treating individuals who are overweight or have obesity. As this is a new medicine, detailed safety information from earlier studies is not yet available. In this first phase of the trial, the primary goal is to ensure the treatment's safety for participants. Researchers closely monitor how well participants tolerate the medicine and check for any side effects.

Participants in the study will receive either the new medicine or a placebo (a dummy medicine). The study will assess how single and multiple doses affect the body. While specific results are not yet available, this phase focuses on confirming the medicine's safety for broader use in the future. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for obesity, which often includes lifestyle changes, medications like orlistat, and sometimes surgery, NNC0638-0355 represents a novel approach. Researchers are excited about NNC0638-0355 because it potentially offers a new mechanism of action that could target obesity differently. While many medications work by suppressing appetite or inhibiting fat absorption, NNC0638-0355 may function by influencing metabolic pathways at a cellular level, potentially leading to more effective weight management. This innovative pathway could offer hope for those who haven't had success with existing treatments.

What evidence suggests that NNC0638-0355 might be an effective treatment for obesity?

Research shows that NNC0638-0355 is a new medicine being tested for overweight and obesity. In this trial, participants will receive either NNC0638-0355 or a placebo at random. The main goal of the studies so far has been to ensure the medicine's safety and understand its mechanism in the body. Although there is limited data on its effectiveness, the focus is on its potential to reduce excess body fat. Early tests aim to explore its effects and assess its viability as a treatment option. As more results become available, they will provide a clearer understanding of NNC0638-0355's effectiveness in managing weight. ^{1 2 3 5 6}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• NNC0638-0355

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.

How Is the Trial Designed?

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).

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

Published Research Related to This Trial

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]

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]

The study identified a new compound, (E)-N2-((naphthalene-1-yl)methylene)-N5-(1H-pyrazol-3-yl)-3H-benzo[d]imidazole-2,5-diamine, as a potent inhibitor of Pancreatic Lipase (PL), achieving 93% inhibition, which is higher than the standard drug Orlistat (91%).

This compound's strong binding affinity and multiple hydrogen bonds with the enzyme suggest it could be an effective treatment for obesity by preventing the digestion of dietary fats, warranting further in vivo and in vitro studies for optimization.

NCBI (Pubmed)

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. Unnisa, A., Huwaimel, B., Almahmoud, S., et al.[2022]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06577766

A Research Study on How NNC0638-0355, a New ... Overweight should be due to excess adipose tissue, as judged by the investigator. Considered to be generally healthy based on the medical history, physical ...

2. trial.medpath.com trial.medpath.com/clinical-trial/152f74124fea74ef/nct06577766-safety-tolerability-pharmacokinetics-nnc0638-0355-overweight-obesity

A Research Study on How NNC0638-0355, a New Medicine ... 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, ...

3. withpower.com withpower.com/trial/phase-1-overweight-8-2024-556d1

NNC0638-0355 for Obesity · Info for Participants 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, ...

4. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN9638-7569.html

A Research Study on How NNC0638-0355, a New ... 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.

5. ctv.veeva.com ctv.veeva.com/study/a-research-study-on-how-nnc0638-0355-a-new-medicine-works-in-people-living-with-overweight-or-obes

A Research Study on How NNC0638-0355, a New Medicine ... 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 ...

6. synapse.patsnap.com synapse.patsnap.com/drug/d937bda614194210973f3043cdf3c652

NNC0638-0355 - Drug Targets, Indications, Patents A randomised, placebo controlled, double blinded study assessing the safety, tolerability and pharmacokinetics of single and multiple subcutaneous doses.