Could a peptide injection help rebuild Insulin-Making cells?
NCT ID NCT02538848
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This early-stage trial is testing an experimental drug called HTD4010, a synthetic version of a natural peptide that may help the pancreas regenerate insulin-producing cells. The study enrolls healthy, non-diabetic volunteers to receive single ascending doses of the drug or a placebo. The main goal is to assess how safe and tolerable the drug is, and how the body processes it, before any potential future studies in people with type 2 diabetes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HTD4010, an experimental injectable analog of the INGAP peptide
- What this could lead to
- If safe and well-tolerated, HTD4010 could pave the way for future studies exploring its potential to help regenerate insulin-producing cells, possibly offering a new approach to treating type 2 diabetes.
- What could go wrong
- This is an early, first-in-human study focused on safety, not effectiveness. The drug may cause unexpected side effects or fail to show promise in later trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
32 people
The number who actually took part.
- Start date
-
Oct 2015
- Finished
-
Mar 2016
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
For volunteers in SAD: Inclusion Criteria: 1. Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2 2. Non-diabetic, fasting plasma glucose \< 5.6 mmol/L 3. Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for ≥12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the participant and his partner must be using an acceptable, highly effective, contraceptive method from screening and for a period of 60 days after the last dose of Study Drug. 4. Ability to provide written informed consent. Exclusion Criteria: 1. Systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>90 mmHg at screening. 2. Pregnant or lactating women 3. Participation in an investigational study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer. 4. Current use of any prescription or over-the-counter (OTC) medications, including herbal products and supplements, within 14 days prior to Day 1 or 5 half-lives, whichever is longer. Use of ≤2g paracetamol per day is allowed prior to and during the study at Investigator discretion. 5. Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing. 6. History of any major surgery within 6 months prior to Screening 7. History of any serious adverse reaction or hypersensitivity to any of the product components. 8. Use of parenterally administered proteins or antibodies within 12 weeks of screening. etc.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Linear Clinical Research Limited
Perth, WA6009, Australia
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Other studies related to the condition(s) this trial covers.
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