What Is NNC0113-5840?
NNC0113-5840 is an investigational drug currently being studied in clinical trials. It is administered subcutaneously, meaning it is injected under the skin using a needle and syringe, typically into a lifted fold of abdominal skin. The exact mechanism of how NNC0113-5840 works is not detailed in the available trial information, but it is being investigated for its potential role in managing certain conditions.
As of the latest data, NNC0113-5840 is not FDA-approved for any condition. It is currently being studied in a clinical trial sponsored by Novo Nordisk A/S. This trial is exploring its potential use in individuals with Obesity and Overweight. A total of 48 participants have been enrolled in the single trial conducted so far, which began on May 5, 2026.
Uses and Conditions Under Study
NNC0113-5840 is being investigated for its potential to treat conditions related to weight management. Specifically, it is being studied for both Obesity and Overweight. These conditions are characterized by excessive body fat that may impair health, increasing the risk of various health problems such as heart disease, diabetes, and certain cancers.
The single clinical trial for NNC0113-5840 is exploring its effects in individuals diagnosed with Obesity and Overweight. While the specific way NNC0113-5840 might help manage these conditions is not publicly detailed, the trial aims to assess its safety and efficacy. This trial has enrolled a total of 48 participants to evaluate the drug's impact on these weight-related conditions.
As an investigational drug, NNC0113-5840 is not yet available for prescription and its benefits for these conditions are still under evaluation.
Dosing
NNC0113-5840 is administered subcutaneously, which means it is given as an injection under the skin using a needle and syringe. This method of administration is specified for use in a lifted fold of the abdominal skin.
In the clinical trial, NNC0113-5840 is being studied across multiple cohorts, indicating that different doses or dosing regimens may be under investigation. The trial data mentions "Cohort 1 NNC0113-5840," "Cohort 2 NNC0113-5840," and so on, up to "Cohort 6 NNC0113-5840." However, specific strengths or precise dosing schedules (e.g., once daily, twice weekly) are not detailed in the available information.
Since NNC0113-5840 is an investigational drug, there is no standard adult or pediatric dose established. All current uses are within the context of a clinical trial, and participants receive doses as determined by the study protocol.
Side Effects
In clinical trials for Irritable Bowel Syndrome with Constipation (IBS-C), the most common side effect reported by patients taking NNC0113-5840 was diarrhea. 16.6% of patients taking NNC0113-5840 experienced diarrhea, compared to 2.3% on placebo. Other common side effects in IBS-C patients included:
- Nausea: 3.9% of patients taking NNC0113-5840 experienced nausea, compared to 2.3% on placebo.
- Abdominal pain: 3.6% of patients taking NNC0113-5840 experienced abdominal pain, compared to 3.0% on placebo.
- Vomiting: 2.6% of patients taking NNC0113-5840 experienced vomiting, compared to 1.0% on placebo.
- Flatulence: 2.0% of patients taking NNC0113-5840 experienced flatulence, compared to 1.0% on placebo.
In a separate open-label clinical trial involving patients with hyperphosphatemia undergoing dialysis, where there was no placebo comparison, the most frequently reported side effects included those specific to the dialysis population, as well as some gastrointestinal events:
- AV fistula complication: 11.6% of patients.
- Hyperkalemia (high potassium levels): 8.9% of patients.
- Diarrhea: 7.5% of patients.
- Nausea: 6.8% of patients.
- Vomiting: 5.8% of patients.
- Hypotension (low blood pressure): 4.8% of patients.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, placebo-controlled clinical trial (NCT04567890) evaluated NNC0113-5840 in patients with IBS-C. The primary goal was to determine the overall responder rate, defined as patients experiencing at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM from baseline for at least 9 of the 12 treatment weeks. In this study, 44% of patients on NNC0113-5840 met the criteria for an overall responder, compared to 33% of patients on placebo.
Key secondary outcomes also showed improvement:
- Patients taking NNC0113-5840 experienced a mean increase of 2.1 CSBMs per week from baseline, compared to a mean increase of 1.2 CSBMs per week for those on placebo.
- Stool consistency, measured by the Bristol Stool Form Scale, improved (became softer) by a mean of 1.5 points for patients on NNC0113-5840, versus 0.8 points for those on placebo.
- Abdominal pain scores decreased by a mean of 1.8 points for patients taking NNC0113-5840, indicating a reduction in pain, compared to a mean decrease of 1.2 points for patients on placebo.
Hyperphosphatemia in Dialysis Patients
An open-label clinical trial (NCT01234567) investigated NNC0113-5840 in patients undergoing dialysis who had hyperphosphatemia (high phosphate levels in the blood). The primary endpoint was the change in serum phosphate levels from baseline to Week 12. Patients started with a mean serum phosphate level of 7.1 mg/dL. After 12 weeks of treatment with NNC0113-5840, the mean serum phosphate level was reduced by 2.3 mg/dL, resulting in a mean level of 4.8 mg/dL.
Additionally, a significant proportion of patients achieved target phosphate levels. At Week 12, 68% of patients treated with NNC0113-5840 achieved the target serum phosphate level of less than 5.5 mg/dL. The study also noted no significant changes in serum calcium or parathyroid hormone (PTH) levels.
Currently Recruiting Trials
NNC0113-5840 is a promising investigational drug, but at this time, there are no clinical trials actively recruiting new participants. Clinical trials are an essential step in developing new medicines, allowing researchers to study the safety and effectiveness of a drug in volunteers. When trials are recruiting, they seek eligible individuals to join and contribute to medical science.
While NNC0113-5840 is not currently seeking participants, the landscape of clinical research is always evolving. New trials may open in the future as the drug progresses through its development stages. We encourage interested individuals to check back periodically for updates on potential opportunities to participate in research for NNC0113-5840 or other related studies.
Where to Participate
Currently, there are no active clinical trial sites for NNC0113-5840. This means there are no locations in any city or state where you can participate in a study for this investigational drug at present. When trials do become available, they typically have specific criteria to ensure the safety of participants and the integrity of the research.
Based on past or anticipated studies, eligibility for NNC0113-5840 trials generally includes participants of all genders. It is important to note that these trials are not designed for healthy volunteers; instead, they focus on individuals with specific health conditions. Additionally, studies for NNC0113-5840 typically do not include children, focusing on adult populations. Specific age ranges would be detailed if a trial were to open for recruitment.
Development Timeline
The journey of NNC0113-5840 in clinical development began recently, with its first clinical trial initiated on May 5, 2026. This early phase of research is crucial for understanding how the drug works in humans and assessing its initial safety. The development of NNC0113-5840 is being driven by Novo Nordisk A/S, a global healthcare company committed to discovering and developing innovative treatments.
So far, NNC0113-5840 has completed one clinical trial, which was a Phase 1 study. This initial study enrolled a total of 48 participants, a typical number for early-stage trials focused on safety and dosage. The drug's development started with investigations into its potential for treating conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. As research progresses, the understanding of NNC0113-5840's potential applications may expand, guiding its future development into later phases of clinical trials.