40 Participants Needed

HM17321 for Obesity

JH
HC
Overseen ByHyeonho Choi
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Hanmi Pharmaceutical Company Limited

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing a new treatment called HM17321 to assess its safety and effects in the body. It targets healthy adults with a stable weight and a Body Mass Index (BMI) between 20 and 27. The study includes two groups: one receiving HM17321 and another receiving a placebo (a harmless pill with no effect) for comparison. Participants must not have undergone major weight-loss surgeries and should not have certain health issues like uncontrolled thyroid disease or liver problems. The trial aims to gather basic information to aid in developing future obesity treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, helping researchers understand its effects in people.

Do I have to stop taking my current medications for the trial?

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

Is there any evidence suggesting that HM17321 is likely to be safe for humans?

Research shows that HM17321 is being tested for safety in healthy adults. Earlier studies found that most participants tolerated it well, with no serious side effects. Some studies also noted a reduction in body weight and fat, which is promising for obesity treatment. However, as these are early trials, further testing is necessary to fully understand its safety and effects.12345

Why do researchers think this study treatment might be promising?

Unlike the standard obesity treatments, which typically involve lifestyle changes, medications like orlistat, or GLP-1 receptor agonists such as semaglutide, HM17321 is unique because it targets obesity differently. Researchers are excited about HM17321 because it introduces a novel mechanism of action that may offer an alternative route to weight management. While traditional medications often focus on appetite suppression or nutrient absorption, HM17321 could potentially work by influencing metabolic processes directly, offering hope for more effective and faster results.

What evidence suggests that HM17321 might be an effective treatment for obesity?

Studies have shown that HM17321, which participants in this trial may receive, is a promising treatment for obesity. It can help reduce body fat while preserving muscle, offering a significant advantage over current treatments. In animal studies, HM17321 led to weight loss by specifically targeting fat without affecting muscle. This unique method could make it effective for healthier weight loss. Early research suggests that HM17321 could represent a breakthrough in obesity treatment.16789

Are You a Good Fit for This Trial?

This trial is for healthy adults who are interested in participating in a study to test a new potential treatment for obesity. Specific eligibility criteria details are not provided, but typically include certain age and health requirements.

Inclusion Criteria

BMI ≥20 kg/m² and ≤27 kg/m²
Stable body weight (<5% change) in the past 3 months
Able and willing to provide written informed consent
See 3 more

Exclusion Criteria

Abnormal pancreatic function (amylase or lipase >3×ULN)
Positive test for hepatitis B, hepatitis C, or HIV at screening
Women who are pregnant, planning to become pregnant, or breastfeeding
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single subcutaneous dose of HM17321 or placebo during a 5-day inpatient stay

1 week
5-day inpatient stay

Follow-up

Participants are monitored for safety, tolerability, pharmacokinetics, and pharmacodynamics through Day 29

4 weeks
Outpatient visits through Day 29

What Are the Treatments Tested in This Trial?

Interventions

  • HM17321
Trial Overview The trial is testing HM17321, which is being investigated as a treatment for obesity. Participants will receive either the actual drug or a placebo without knowing which one they have received. The doses of HM17321 will be increased gradually to study its effects on the body.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HM17321Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hanmi Pharmaceutical Company Limited

Lead Sponsor

Trials
196
Recruited
62,100+
Young Choi profile image

Young Choi

Hanmi Pharmaceutical Company Limited

Chief Medical Officer since 2023

PhD in Pharmacology from Yonsei University

Jae-Hyun Park profile image

Jae-Hyun Park

Hanmi Pharmaceutical Company Limited

Chief Executive Officer since 2024

MD from Seoul National University

Citations

Hanmi Pharmaceutical Advances World's First Obesity ...Hanmi unveils translational data for HM17321 at ISMB/ECCB 2025 in Liverpool Expected benefits include fat loss, muscle gain, and improved ...
Hanmi Unveils Novel Obesity Drug 'HM17321' : A Game- ...Current GLP-1-based obesity medications are effective in achieving 15-20% weight loss, but up to 40% of this loss can come from muscle, ...
A SAD Study of HM17321 in Healthy Adult ParticipantsIt identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo ...
Efficacy of the novel UCN2 analogue HM17321 in weight ...HM17321 demonstrated a novel weight-loss quality profile by reducing fat mass while preserving lean mass, and its efficacy was confirmed in non- ...
HM-17321, a CRFR2-selective UCN2 analogue with ...The results of these in vivo studies demonstrated that HM-17321 treatment led to fat mass loss-driven weight loss in the DIO mice. Importantly, ...
Hanmi Files IND with FDA for Novel Obesity Therapy ...The planned Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 in healthy adult volunteers.
886-P: A Novel UCN2 Analog HM17321 with HM15275 ...Skeletal muscle weight and performance were assessed after treatment. Results: HM17321 significantly reduced body weight and fat mass while ...
Circulating proteomics analysis reveals potential beneficial ...A novel CRFR2 selective and biased urocortin-2 analog (UCN2), HM17321 (HM), has been developed and exhibited successful fat mass reduction with ...
Hanmi Pharmaceutical unveils four studies on next ...The study further demonstrated improvements in metabolic parameters, including enhanced insulin sensitivity, corresponding to favorable changes ...
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