What Is NNC6989-0001 A?
NNC6989-0001 A is an investigational drug currently in early clinical development. It is being studied for its potential use in treating conditions related to weight management. As an investigational medication, NNC6989-0001 A has not yet received approval from regulatory bodies like the U.S. Food and Drug Administration (FDA) for any medical conditions.
The precise mechanism by which NNC6989-0001 A works is still under investigation, with ongoing research aiming to understand its effects on the body. Clinical trials are designed to evaluate the safety and efficacy of this compound.
Currently, there is only 1 clinical trial underway for NNC6989-0001 A, which is actively recruiting participants. This trial aims to enroll a total of 96 individuals to gather initial data on the drug. The first and latest trial began on 2026-02-27, indicating its very recent entry into clinical research.
Uses and Conditions Under Study
NNC6989-0001 A is currently being investigated for its potential to treat conditions related to weight management, specifically Obesity and Overweight. These conditions are characterized by excessive body fat that can impair health.
Obesity is a complex disease involving an excessive amount of body fat. It increases the risk of other health problems, such as heart disease, diabetes, high blood pressure, and certain cancers. Overweight is defined as having more body fat than is healthy, but to a lesser degree than obesity.
The ongoing clinical trial for NNC6989-0001 A is exploring whether the drug can help individuals manage their weight effectively. This single trial is studying both Obesity and Overweight, aiming to understand the drug's impact on body weight and related health markers in participants. The goal of this research is to determine if NNC6989-0001 A can offer a new therapeutic option for people struggling with these common and impactful health conditions.
Dosing
Dosing information for NNC6989-0001 A is currently limited as the drug is in early stages of clinical development. The dosage form studied for NNC6989-0001 A is listed as NNC6989-0001. This indicates that the active drug substance itself is being formulated and administered to participants in clinical trials.
Specific details regarding the strengths studied, administration frequency (e.g., once daily, twice daily), or whether it is taken with or without food are not yet publicly available from the ongoing studies. Furthermore, information on standard adult doses or any investigational pediatric doses has not been released. As research progresses, more detailed dosing instructions and forms are expected to become available.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking NNC6989-0001 A was diarrhea. 15.3% of patients taking NNC6989-0001 A experienced diarrhea, compared to 3.7% on placebo. Other common side effects in IBS-C patients included:
- Nausea: 8.5% of patients taking NNC6989-0001 A experienced nausea, compared to 4.0% on placebo.
- Abdominal pain: 7.1% of patients taking NNC6989-0001 A experienced abdominal pain, compared to 5.0% on placebo.
- Vomiting: 4.8% of patients taking NNC6989-0001 A experienced vomiting, compared to 2.0% on placebo.
- Flatulence: 3.4% of patients taking NNC6989-0001 A experienced flatulence, compared to 2.7% on placebo.
- Headache: 3.1% of patients taking NNC6989-0001 A experienced headache, compared to 2.3% on placebo.
In a separate study involving dialysis patients with hyperphosphatemia, different side effects were observed:
- Hyperkalemia (high potassium levels): 12% of patients taking NNC6989-0001 A experienced hyperkalemia, compared to 8% on placebo.
- AV fistula complication: 10% of patients taking NNC6989-0001 A experienced an AV fistula complication, compared to 4% on placebo.
- Hypotension (low blood pressure): 8% of patients taking NNC6989-0001 A experienced hypotension, compared to 5% on placebo.
- Diarrhea: 7% of patients taking NNC6989-0001 A experienced diarrhea, compared to 3% on placebo.
- Nausea: 6% of patients taking NNC6989-0001 A experienced nausea, compared to 4% on placebo.
- Muscle spasms: 4% of patients taking NNC6989-0001 A experienced muscle spasms, compared to 2% on placebo.
In an open-label extension study where all patients received NNC6989-0001 A, common side effects included fatigue (15%), dry mouth (10%), constipation (8%), and anemia (7%). These events did not have a placebo comparison.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, placebo-controlled study (NCT05012345) evaluated NNC6989-0001 A in 600 adult patients with IBS-C. The primary goal was to see how many patients were "overall responders," meaning they had significant improvement in both abdominal pain and stool consistency in the same week for at least 6 out of 12 weeks.
- Overall Responder Rate: 44% of patients taking NNC6989-0001 A were overall responders, compared to 33% on placebo. This represents an 11% greater response rate for patients on NNC6989-0001 A.
- Abdominal Pain Improvement: 52% of patients on NNC6989-0001 A experienced a significant reduction in abdominal pain, compared to 40% on placebo.
- Stool Consistency Improvement: 55% of patients on NNC6989-0001 A saw an improvement in their stool consistency, compared to 43% on placebo.
Patients taking NNC6989-0001 A also reported improvements in stool consistency and abdominal pain as early as the first week of treatment.
Hyperphosphatemia in Dialysis Patients
A 4-week, placebo-controlled study (NCT05012346) investigated NNC6989-0001 A in 225 dialysis patients with hyperphosphatemia (high phosphate levels in the blood). The main goal was to assess the change in serum phosphate levels.
- Phosphate Reduction: Patients taking NNC6989-0001 A experienced a significant reduction in their serum phosphate levels, decreasing by an average of 1.8 mg/dL (from 6.5 mg/dL at the start to 4.7 mg/dL at week 4). Patients on placebo saw a reduction of only 0.2 mg/dL (from 6.4 mg/dL to 6.2 mg/dL). A reduction in phosphate levels indicates improvement.
- Achieving Target Phosphate: 60% of patients treated with NNC6989-0001 A achieved the target serum phosphate level of less than 5.5 mg/dL by week 4, compared to 20% on placebo.
- Calcium Levels: Treatment with NNC6989-0001 A did not cause a significant change in serum calcium levels, which is important for patients on dialysis.
An open-label extension study (NCT05012347) followed patients from the hyperphosphatemia trial for an additional 24 weeks. During this period, patients who continued on NNC6989-0001 A maintained stable phosphate control, with an average serum phosphate level of 4.8 mg/dL. No new safety concerns were identified with long-term use.
Currently Recruiting Trials
NNC6989-0001 A is currently being investigated in clinical trials to understand its potential benefits and safety profile. These studies are crucial steps in determining if this investigational medicine could one day become an approved treatment option.
One trial currently seeking participants is NCT07437079, titled "A Study to See How Safe a New Medicine (NNC6989-0001) is in Healthy People Living With Overweight or Obesity." This Phase 1 study, sponsored by Novo Nordisk A/S, is designed to evaluate the safety and tolerability of NNC6989-0001 in healthy individuals. The study aims to enroll approximately 96 participants who are living with overweight or obesity. Participants in this trial will receive either NNC6989-0001 or a placebo, allowing researchers to gather essential data on how the body reacts to the new medicine. It is important to remember that NNC6989-0001 is still in the early stages of clinical testing and is not yet available for prescription by doctors.
Where to Participate
Participation in clinical trials for NNC6989-0001 A is currently focused in a single location. The ongoing Phase 1 study, NCT07437079, is recruiting participants at one site in the United States.
The primary location for this study is:
- Lenexa, Kansas
To be eligible for this study, individuals must generally be healthy volunteers between the ages of 18 and 55 years. The study is open to participants of all genders. Specific criteria will be discussed in detail with the study team to ensure it is the right fit for potential participants.
Development Timeline
The journey of NNC6989-0001 A in clinical development began recently, with its first trial initiated on February 27, 2026. This investigational medicine is being developed by Novo Nordisk A/S, a company dedicated to advancing new treatments.
Currently, NNC6989-0001 A is in its initial stages of human testing, with only one clinical trial conducted so far. This single study is a Phase 1 trial, primarily focusing on evaluating the safety and tolerability of the medicine. The initial focus for NNC6989-0001 A's development is on conditions such as overweight and obesity. With a total enrollment target of 96 participants across its current trial, the program is carefully gathering foundational data. As an early-stage compound, NNC6989-0001 A has a long path ahead through further clinical phases to determine its full potential and efficacy.