NCT06615700CompletedPhase 1
Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and Patients With Type 2 Diabetes Mellitus
A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NA-931 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 27 Sept 2024
Brief summary (registry, in English)
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 74 (actual)
- First submitted
- 24 Sept 2024
- Start date
- 6 May 2024
- Primary completion date
- 12 Aug 2024
- Lead sponsor
- Biomed Industries, Inc.
- Diseases
- Obesity, Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06615700
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 74
- From 6 May 2024 to the primary completion date, 12 Aug 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of alcoholism or drug addiction within 1 year prior to Screening
Other illness
- History of significant medical conditions and malignancy
- Uncontrollable hypertension
- Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
Other
- Current or recent participation in an investigational clinical trial
Who the study is looking for
- Participants 18-65 years old, inclusive
- BMI of 25 - 40, inclusive
- Stable body weight for two months
- Participants must be capable of giving signed informed consent
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
- Willing to comply with contraception requirements
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Biomed Industries Pty Limited- Clinical Testing Site 1 Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Biomed Industries, Pty Limited Testing Site 2 Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.