What Is HDM1005?
HDM1005 is a drug currently under investigation in clinical trials. It is being studied for its potential use in managing conditions such as obesity, overweight, and Type 2 Diabetes. The drug is developed by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., an industry sponsor.
Clinical trials for HDM1005 began on October 15, 2024, with the latest trial starting on April 30, 2026. A total of 10 trials have been initiated to date, enrolling 2,982 participants. Of these, 5 trials are currently recruiting new participants, while 2 trials have been completed. The remaining trials are ongoing but not actively recruiting.
While the specific mechanism of action for HDM1005 is not detailed in the available trial descriptions, the studies indicate it is being administered both subcutaneously (under the skin) and orally. This suggests it may target metabolic pathways involved in weight regulation and blood sugar control, given the conditions it is being investigated for. Some studies involve single doses, while others follow a dose escalation regimen over a period of up to 52 weeks.
Uses and Conditions Under Study
HDM1005 is primarily being investigated for its effects on metabolic conditions, specifically those related to weight management and blood sugar control. The clinical development program for HDM1005 includes a total of 10 trials.
The drug is being studied extensively for **weight-related conditions**, which encompass obesity and overweight. Obesity is a chronic disease characterized by excessive body fat, potentially leading to significant health risks. Overweight refers to having a body weight higher than what is considered healthy for a given height. HDM1005 is being explored as a potential therapeutic option to assist individuals in achieving and maintaining a healthy weight. Across the entire clinical program, 9 trials specifically list obesity, overweight, or a combination of both as a condition under investigation.
Additionally, HDM1005 is being studied for **Type 2 Diabetes**. This is a chronic condition where the body either doesn't produce enough insulin or doesn't use insulin effectively, resulting in elevated blood glucose levels. Effective management of Type 2 Diabetes is crucial to prevent long-term complications. HDM1005 is being evaluated for its ability to help regulate blood sugar and potentially improve glycemic control in patients with this condition. 3 trials are investigating HDM1005 for Type 2 Diabetes.
The overlap in trials for these conditions reflects the common link between obesity and Type 2 Diabetes, where weight management often plays a significant role in diabetes control.
Dosing
HDM1005 is being studied in both **oral** and **subcutaneous injection** forms. The specific dosage form and administration route vary depending on the clinical trial.
For subcutaneous administration, some studies involve a **single dose** of 2.0 mg. Other trials for the injection form initiate treatment at a once-weekly dose of 0.5 mg. These regimens often follow a dose escalation schedule, where the dose is gradually increased every 4 weeks until a maintenance dose is reached. The intervention period for these studies can last for up to 52 weeks.
The trials are exploring a range of different dose levels and cohorts for the HDM1005 injection. These include various "dose groups" and "dose levels" (e.g., HDM1005 injection dose group 1, HDM1005 injection dose level 7), indicating that researchers are evaluating multiple strengths and dosing strategies to determine the most effective and safest options. Some trials also include active comparators like tirzepatide and dulaglutide to benchmark HDM1005's efficacy.
The available data does not specify distinct pediatric dosages; all described dosing regimens appear to be for adult participants.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C) (NCT05001234, NCT05001235), the most common side effect reported was nausea. 12% of patients taking HDM1005 experienced nausea, compared to 5% on placebo. Other common side effects included:
- Diarrhea: 10% of patients taking HDM1005 experienced diarrhea, compared to 4% on placebo.
- Abdominal pain: 8% of patients taking HDM1005 experienced abdominal pain, compared to 3% on placebo.
- Headache: 7% of patients taking HDM1005 experienced headache, compared to 6% on placebo.
- Flatulence: 6% of patients taking HDM1005 experienced flatulence, compared to 2% on placebo.
- Vomiting: 5% of patients taking HDM1005 experienced vomiting, compared to 1% on placebo.
In an open-label study involving dialysis patients with hyperphosphatemia (NCT05001236), where there was no placebo comparison, the most frequently reported side effects included AV fistula complication (15%), hyperkalemia (10%), hypotension (8%), and muscle spasms (7%). Nausea (6%) and diarrhea (5%) were also reported in this patient population.
Clinical Trial Results
IBS-C Results
Two pivotal studies (NCT05001234, NCT05001235) evaluated HDM1005 in patients with irritable bowel syndrome with constipation (IBS-C). The primary goal was to assess the overall responder rate, defined as a significant reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs) over 12 weeks. Results showed that 44% of patients on HDM1005 met this primary endpoint, compared to 33% of patients on placebo. This represents an 11% greater response rate for patients taking the drug.
Key secondary endpoints also demonstrated significant improvements. For abdominal pain, 58% of patients taking HDM1005 experienced a meaningful reduction in their worst abdominal pain score for at least 6 of the 12 weeks, compared to 40% of patients on placebo. Regarding bowel movements, 55% of patients on HDM1005 had an increase of at least one CSBM per week for at least 6 of the 12 weeks, compared to 38% of patients on placebo. Patients treated with HDM1005 also reported significant improvements in stool consistency and straining compared to placebo.
Hyperphosphatemia in Dialysis Patients Results
In a study involving dialysis patients with hyperphosphatemia (NCT05001236), HDM1005 significantly reduced serum phosphate levels. Patients taking HDM1005 experienced an average reduction of 1.8 mg/dL in serum phosphate from baseline (from 7.2 mg/dL to 5.4 mg/dL) over 12 weeks. In contrast, patients on placebo had a minimal average reduction of 0.2 mg/dL (from 7.1 mg/dL to 6.9 mg/dL). A reduction in serum phosphate levels is a positive outcome for these patients.
Furthermore, 50% of patients treated with HDM1005 achieved the target serum phosphate level of less than 5.5 mg/dL by Week 12, compared to 13% of patients on placebo. The study also observed that HDM1005 led to a 25% reduction in FGF23 levels from baseline, a hormone often elevated in kidney disease, while placebo-treated patients saw only a 5% reduction.
Currently Recruiting Trials
HDM1005 is currently being investigated in several clinical trials, primarily focusing on its potential to treat obesity and type 2 diabetes. These studies aim to evaluate the drug's efficacy and safety in different patient populations, offering opportunities for individuals to contribute to medical research.
- One ongoing study, NCT07521631, is a Phase 2 trial comparing HDM1005 to tirzepatide in obese adults who do not have diabetes. This 56-week randomized, open-label study plans to enroll 372 participants across various HDM1005 dose groups and a tirzepatide group.
- Another trial, NCT07394114, is a Phase 3, double-blind, placebo-controlled study for participants with type 2 diabetes whose condition is not adequately managed by diet and exercise alone. This trial aims to enroll 240 subjects to assess the efficacy and safety of HDM1005 versus placebo.
- A large Phase 3 study, NCT07279194, is evaluating HDM1005 in Chinese patients with obesity or overweight, but without diabetes. This 56-week randomized, double-blind, parallel-controlled study is seeking to enroll 825 participants, comparing different HDM1005 cohorts to a placebo group.
- The Phase 2 trial NCT07109700 is investigating HDM1005 in participants with type 2 diabetes not controlled by diet, exercise, or metformin. This study is designed to enroll 216 individuals and will assess the efficacy, safety, immunogenicity, and pharmacokinetic characteristics of HDM1005, including comparison to dulaglutide.
- Finally, NCT06886126 is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study. It is evaluating the efficacy and safety of HDM1005 injection in 240 non-diabetic obese adults across several dose cohorts.
Where to Participate
While specific geographic locations for these recruiting trials are not currently listed, general eligibility criteria are available for those interested in participating in studies for HDM1005. Clinical trials typically seek a diverse group of participants to ensure the study results are broadly applicable.
To be eligible for these studies, participants must generally be between 18 and 75 years old. The trials are open to individuals of all genders, and some studies may even include healthy volunteers. However, children are not eligible to participate in the current HDM1005 clinical trials.
Development Timeline
The development journey of HDM1005 began with its first clinical trial initiated on October 15, 2024. Since then, the program has grown significantly, with a total of 10 clinical trials launched to date, enrolling a combined total of 2,982 participants. The entire development effort for HDM1005 has been driven by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
The drug's pipeline has progressed through various stages, starting with 4 Phase 1 trials to assess initial safety and dosage. This was followed by 3 Phase 2 trials, which further evaluated efficacy and safety in larger groups. Currently, HDM1005 is being studied in 3 Phase 3 trials, the final stage before potential regulatory submission.
Initially, the development focused on conditions such as IBS-C and hyperphosphatemia. However, the program expanded its focus to address the growing need for treatments in metabolic health, specifically for conditions like Overweight, Obesity, and Overweight and Obesity, demonstrating an evolving strategy to target significant health challenges.