Healthy VolunteerPhase 1NCT06739707
Subcutaneously Administered MD-18 for the Treatment of Obesity and Diabetes
A Phase 1 study testing MD-18 in people with Healthy Volunteer, run by Cohen Global, Ltd. at 1 site in Israel.
Trial summary
A Multiple Dose, Randomized, Placebo-controlled, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered MD-18 for healthy subjects with overweight or obesity Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- MD-18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Jan 2025to Dec 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 18-70 years, both genders.
- BMI:
- Cohorts 1-6: 25-34.9
- Cohort 7: 30.0-44.9
- HbA1c <6.5%
- Healthy as determined by a physician, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory function. History must comply with the following:
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- Absence of clinically significant illness or major surgery within the preceding 12 weeks.
- Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease as per PI decision.
- Male subjects with female partners of childbearing potential must agree to utilize an approved contraceptive during the study.
- Female subjects of child-bearing potential with negative urine pregnancy test at screening and who agree to use contraception during the study.
- Female subjects of non-child-bearing potential (i.e. tubal ligation, hysterectomy, or postmenopausal).
- Subjects must provide written informed consent and be willing and able to comply with study procedures.
Who cannot join
- History of excessive alcohol use (defined as >21 drinks per week for males and >14 drinks per week for females), recreational drug use within the past three months, or failure on urinary drug screen. Note: use of Cannabinoids for medical purposes is allowed.
- Pregnant or breastfeeding within six months of screening assessment.
- Substantial changes in eating habits or exercise routine within the preceding three months.
- Evidence of eating disorders.
- >5% weight change in the past three months.
- Bariatric surgery within the past five years.
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- Moderate renal impairment ( Glomerular filtration rate<60 mg/mL/1.73m2)
- Liver function tests greater than twice the upper limit of normal upon repeated measurements.
- Diseases interfering with metabolism and or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression).
- Use of medications affecting body weight within the past three months, unless on a stable dose, with weight stability in the preceding three months. These medications include:
- Drugs approved for the treatment of obesity
- Cyproheptadine or medroxyprogesterone
- Atypical anti-psychotic drugs
- Tricyclic antidepressants
- Lithium, MAO's, glucocorticoids
- SSRIs or SNRIs
- Anti-epileptic drugs
- Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
- A baseline (screening echocardiogram result) prolongation of ventricular activation and recovery interval after repeated measurements of >450 milliseconds; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome.
- Use drugs of abuse within the preceding three months.
- The last dose of an investigational drug in other clinical trial was within the month prior to dosing in the present study. Note: Volunteers from the previous Phase 1a trial (MD-18-01) may be recruited for the current study, provided that at least 12 weeks have passed since their last dose of the investigational product.
- A positive result for any of the following tests: hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency viruses (HIV) and Treponema pallidum.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple Dose, Randomized, Placebo-controlled, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered MD-18 for Healthy Subjects With Overweight or Obesity
A Multiple Dose, Randomized, Placebo-controlled, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered MD-18 for healthy subjects with overweight or obesity
Read the detailed description
This study will be conducted as a single center study, at the Sheba Medical Center, Israel. Escalating daily doses of MD-18 or placebo will be administered subcutaneously to each subject over a 4-week period with a 7-day follow-up period. 54 patients will be enrolled across 7 cohorts. Each of the cohorts will enroll 4 active and two placebo subjects, except for the final cohort. Cohort 7 will be comprised of obese subjects and will enroll 12 active and 6 placebo subjects. Starting dose has been determined from the SAD study (CG MD-18-01). Cohorts will receive 74 mg MD-18 three times weekly, (starting dose), 114 mg three times weekly, 227 mg three times weekly, 302 mg once weekly, 302 mg three times weekly or 302 mg daily using 4:2 (active:placebo) randomization; all doses refer to the MD-18 salt. A total of 36 subjects will receive active therapy across seven cohorts (24 in the first six cohorts and 12 in the seventh cohort) and 18 subjects will receive placebo. The study will be conducted on an outpatient basis, with visits performed as shown in the schedule of events.
- Conditions
- Healthy Volunteer
- Being tested
- MD-18, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD-18Drug
MD-18 administered subcutaneously to healthy individuals with overweight or obesity.
PlaceboDrug
Placebo administered subcutaneously to healthy individuals with overweight or obesity.
| Study group | Role | What they receive |
|---|---|---|
| A dose of 74 mg of MD-18 or placebo three times per week for 4 consecutive weeks | Experimental | Cohort 1: Four subjects will be administered a dose of 74 mg of MD-18 and two will receive placebo subcutaneously three times per week for 4 consecutive weeks Receives: Drug: MD-18; Drug: Placebo |
| A dose of 114 mg of MD-18 or placebo three times per week for 4 consecutive weeks | Experimental | Cohort 2: Four subjects will be administered a dose of 114 mg of MD-18 and two will receive placebo subcutaneously three times per week for 4 consecutive weeks. Receives: Drug: MD-18; Drug: Placebo |
| A dose of 227 mg of MD-18 or placebo three times per week for 4 consecutive weeks | Experimental | Cohort 3: Four subjects will be administered a dose of 227 mg of MD-18 and two will receive placebo subcutaneously three times per week for 4 consecutive weeks. Receives: Drug: MD-18; Drug: Placebo |
| A weekly dose of 302 mg of MD-18 or placebo for 4 consecutive weeks | Experimental | Cohort 4: Four subjects will be administered a weekly dose of 302 MD-18 and two will receive placebo subcutaneously for 4 consecutive weeks. Receives: Drug: MD-18; Drug: Placebo |
| A dose of 302 mg of MD-18 or placebo three times per week for 4 consecutive weeks | Experimental | Cohort 5: Four subjects will be administered a dose of 302 mg of MD-18 and two will receive placebo subcutaneously three times per week for 4 consecutive weeks. Receives: Drug: MD-18; Drug: Placebo |
| A daily dose of 302 mg of MD-18 or placebo for 4 consecutive weeks | Experimental | Cohort 6: Four subjects will be administered a daily dose of 302 mg of MD-18 and two will receive placebo subcutaneously for 4 consecutive weeks. Receives: Drug: MD-18; Drug: Placebo |
| The highest tolerated dose/dose-frequency identified in the first six cohorts | Experimental | Cohort 7: Twelve non-diabetic obese subjects will be treated with the highest tolerated dose/dose-frequency identified in the first six cohorts and six subjects will be administered placebo. Receives: Drug: MD-18; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Adverse events.
All adverse events, exacerbations of concomitant illnesses, or events known to be related to underlying disease processes or concomitant medications are to be recorded on the case report form throughout the study. Should there be more than 2 subjects receiving MD-18 with an adverse event grade 4 or 5 that is at least possibly related to MD-18, the study will be put on immediate hold and the data will be reviewed by the site Principal Investigator (PI) and the company Chief Medical Officer (CMO) before proceeding.
Measured: Through study completion, an average of 8 months
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of body temperature.
Body temperature measurements in Celsius (°C) will be conllected at the visits specified in the study protocol's Schedule of Events. If any clinically significant findings or machine/equipment errors occur, the measurement will be repeated. Any confirmed clinically significant result will be recorded as adverse events (AEs).
Measured: During the following study visits: Screening, Day 1,7,14,21,28 and 35) and at the study visits of the 8 weeks study extension period on days 42,56,70,84 and 92 (Only for subjects that have agreed to participate from Cohort 7)
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Serum chemistry.
Collection of blood samples for serum chemistry
Measured: During the screening visit, Day 1, 7,28,35 and at the study visits of Day 56,84 and 92 at the 8 weeks study extension period (Only for subjects that have agreed to participate from Cohort 7).
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of body weight
Body weight (in kilograms) will be measured. To ensure consistency and accuracy, all subjects will be measured while wearing only undergarments or light clothing, without shoes. A calibrated scale will be used consistently throughout the study. In addition, weight measurements along with the screening height measurement will be combined to report BMI in kg/m^2
Measured: During each study visit and at the study visits of the 8 weeks study extension period (Only for subjects that have agreed to participate from Cohort 7)
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Electrocardiogram examination.
12-lead triplicate ECGs will be obtained.
The ECG machine will automatically calculate the following:
Heart rate ( refers to the number of contractions of the heart per minute) PR interval (PR interval is the time from the beginning of the P wave (atrial depolarization) to the beginning of the QRS complex.
QRS complex (represents the depolarization of ventricles And the beginning of systole and ventricular contraction).
QT interval (is the time from the beginning of the QRS complex, representing ventricular depolarization, to the end of the T wave, resulting from ventricular repolarization).
QTc interval (is the QT interval corrected for heart rate).
Measured: at screening (visit 1; Day -7) and days 7, 28 and 35. On Day 92 (for the 8 weeks extension period Only for subjects that have agreed to participate from Cohort 7).
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of respiration rate
Respiration rate in breaths per minute will be collected at the visits specified in the study protocol's Schedule of Events. If any clinically significant findings or machine/equipment errors occur, the measurement will be repeated. Any confirmed clinically significant result will be recorded as adverse events.
Measured: During the following study visits: Screening, Day 1,7,14,21,28 and 35) and at the study visits of the 8 weeks study extension period on days 42,56,70,84 and 92 (Only for subjects that have agreed to participate from Cohort 7)
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of heart rate
Heart rate in beats per minute will be collected at the visits specified in the study protocol's Schedule of Events. If any clinically significant findings or machine/equipment errors occur, the measurement will be repeated. Any confirmed clinically significant result will be recorded as adverse events.
Measured: During the following study visits: Screening, Day 1,7,14,21,28 and 35) and at the study visits of the 8 weeks study extension period on days 42,56,70,84 and 92 (Only for subjects that have agreed to participate from Cohort 7)
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of systolic and diastolic blood pressure
Systolic and diastolic blood pressure in millimeters of mercury (mmHg) will be collected at the visits specified in the study protocol's Schedule of Events. If any clinically significant findings or machine/equipment errors occur, the measurement will be repeated. Any confirmed clinically significant result will be recorded as adverse events.
Measured: During the following study visits: Screening, Day 1,7,14,21,28 and 35) and at the study visits of the 8 weeks study extension period on days 42,56,70,84 and 92 (Only for subjects that have agreed to participate from Cohort 7)
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Hematology blood test
Collection of Hematology blood test
Measured: During the screening visit, Day 1, 7,28,35 and at the study visits of Day 56,84 and 92 at the 8 weeks study extension period (Only for subjects that have agreed to participate from Cohort 7).
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of coagulation panel
Collection of blood samples for coagulation panel.
Measured: During the screening visit, Day 1, 7,28,35 and at the study visits of Day 56,84 and 92 at the 8 weeks study extension period (Only for subjects that have agreed to participate from Cohort 7).
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Urine analysis
Collection of urine samples for Urine analysis
Measured: During the screening visit, Day 1, 7,28,35 and at the study visits of Day 56,84 and 92 at the 8 weeks study extension period (Only for subjects that have agreed to participate from Cohort 7).
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of height
Height (in centimeters) will be collected only at the screening visit and will be combined with the body weight measurements in order to calculate the body mass index (BMI) in kg/m2. A calibrated scale will be used consistently throughout the study.
Measured: At the study screening visit (Day -28 to day -1 Pre-Treatment)
Secondary outcomes (7)
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of pharmacokinetic for Area Under the Curve (AUC) analysis
Plasma samples will be collected for the pharmacokinetic analysis of Area Under the Curve (AUC) for various time intervals: AUC0-1h, AUC0-2h, AUC0-4h, AUC0-12h, AUC0-24h, and AUCinf.
Pharmacokinetic parameters will be summarized using descriptive statistics at each scheduled assessment time point.
Measured: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of pharmacokinetic for Maximum concentration of MD-18 (Cmax) analysis
Plasma samples will be collected for the pharmacokinetic analysis of Maximum concentration of MD-18 (Cmax).
Measured: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of pharmacokinetic for Minimum concentration of MD-18 between doses (Cmin) analysis
Plasma samples will be collected for the pharmacokinetic analysis of inimum concentration of MD-18 between doses (Cmin).
Pharmacokinetic parameters will be summarized using descriptive statistics at each scheduled assessment time point.
Measured: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Plasma samples for the pharmacokinetics analysis of Time to reach maximum concentration
Plasma samples will be collected for the pharmacokinetic analysis of Time to reach maximum concentration of MD-18 (Tmax).
Pharmacokinetic parameters will be summarized using descriptive statistics at each scheduled assessment time point.
Measured: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of pharmacokinetic for the analysis of Half-life (t½)
Plasma samples will be collected for the pharmacokinetic analysis of the study drug MD-18 Half-life (t½).
Pharmacokinetic parameters will be summarized using descriptive statistics at each scheduled assessment time point.
Measured: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Plasma samples for pharmacokinetics analysis of clearance rate (CL/F)
Plasma samples will be collected for the pharmacokinetic analysis of the study drug MD-18 clearance rate (CL/F).
Pharmacokinetic parameters will be summarized using descriptive statistics at each scheduled assessment time point.
Measured: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Plasma samples for the pharmacokinetics analysis of volume of distribution (V/F)
Plasma samples will be collected for the pharmacokinetic analysis of the study drug MD-18 volume of distribution (V/F).
Pharmacokinetic parameters will be summarized using descriptive statistics at each scheduled assessment time point.
Measured: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start2 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Due to sponsor decision - NO SAFETY ISSUES
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dosing will be in 7 dose cohorts. Cohorts 1 through 6 will be comprised of six subjects in each cohort using 4:2 (active: placebo) randomization. Thus, there will be four subjects receiving drug and two receiving placebo in each cohort. Cohort 7 will comprise 18 Obese subjects, in which 12 subjects will receive MD-18 and six will receive placebo. A total of 54 subjects will be enrolled in this study, with 36 receiving MD-18 and 18 receiving placebo. There is no need to wait for the completion of one cohort (Day 28) before proceeding to the next. Once all subjects for Cohort 1 have been recruited, the site should begin recruitment for Cohort 2, even while Cohort 1 is still ongoing. This process should continue for subsequent cohorts. The highest dose that is safe and tolerable in all subjects will be determined as the Maximum Tolerable Dose .
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cohen Global, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739707
- Sponsor's protocol ID
- MD-18-02
- Status last verified
- May 2026
- First submitted
- 4 Dec 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose, Randomized, Placebo-controlled, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered MD-18 for Healthy Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06739707
- Acronym / sponsor ID
- MD-18-02
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to sponsor decision - NO SAFETY ISSUES
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cohen Global, Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multiple Dose, Randomized, Placebo-controlled, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered MD-18 for healthy subjects with overweight or obesity
Detailed description
This study will be conducted as a single center study, at the Sheba Medical Center, Israel. Escalating daily doses of MD-18 or placebo will be administered subcutaneously to each subject over a 4-week period with a 7-day follow-up period. 54 patients will be enrolled across 7 cohorts. Each of the cohorts will enroll 4 active and two placebo subjects, except for the final cohort. Cohort 7 will be comprised of obese subjects and will enroll 12 active and 6 placebo subjects. Starting dose has been determined from the SAD study (CG MD-18-01). Cohorts will receive 74 mg MD-18 three times weekly, (starting dose), 114 mg three times weekly, 227 mg three times weekly, 302 mg once weekly, 302 mg three times weekly or 302 mg daily using 4:2 (active:placebo) randomization; all doses refer to the MD-18 salt. A total of 36 subjects will receive active therapy across seven cohorts (24 in the first six cohorts and 12 in the seventh cohort) and 18 subjects will receive placebo. The study will be conducted on an outpatient basis, with visits performed as shown in the schedule of events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Dosing will be in 7 dose cohorts. Cohorts 1 through 6 will be comprised of six subjects in each cohort using 4:2 (active: placebo) randomization. Thus, there will be four subjects receiving drug and two receiving placebo in each cohort. Cohort 7 will comprise 18 Obese subjects, in which 12 subjects will receive MD-18 and six will receive placebo. A total of 54 subjects will be enrolled in this study, with 36 receiving MD-18 and 18 receiving placebo. There is no need to wait for the completion of one cohort (Day 28) before proceeding to the next. Once all subjects for Cohort 1 have been recruited, the site should begin recruitment for Cohort 2, even while Cohort 1 is still ongoing. This process should continue for subsequent cohorts. The highest dose that is safe and tolerable in all subjects will be determined as the Maximum Tolerable Dose .
| Arm | Type | Receives |
|---|---|---|
| A dose of 74 mg of MD-18 or placebo three times per week for 4 consecutive weeks | Experimental | Drug: MD-18, Drug: PlaceboCohort 1: Four subjects will be administered a dose of 74 mg of MD-18 and two will receive placebo subcutaneously three times per week for 4 consecutive weeks |
| A dose of 114 mg of MD-18 or placebo three times per week for 4 consecutive weeks | Experimental | Drug: MD-18, Drug: PlaceboCohort 2: Four subjects will be administered a dose of 114 mg of MD-18 and two will receive placebo subcutaneously three times per week for 4 consecutive weeks. |
| A dose of 227 mg of MD-18 or placebo three times per week for 4 consecutive weeks | Experimental | Drug: MD-18, Drug: PlaceboCohort 3: Four subjects will be administered a dose of 227 mg of MD-18 and two will receive placebo subcutaneously three times per week for 4 consecutive weeks. |
| A weekly dose of 302 mg of MD-18 or placebo for 4 consecutive weeks | Experimental | Drug: MD-18, Drug: PlaceboCohort 4: Four subjects will be administered a weekly dose of 302 MD-18 and two will receive placebo subcutaneously for 4 consecutive weeks. |
| A dose of 302 mg of MD-18 or placebo three times per week for 4 consecutive weeks | Experimental | Drug: MD-18, Drug: PlaceboCohort 5: Four subjects will be administered a dose of 302 mg of MD-18 and two will receive placebo subcutaneously three times per week for 4 consecutive weeks. |
| A daily dose of 302 mg of MD-18 or placebo for 4 consecutive weeks | Experimental | Drug: MD-18, Drug: PlaceboCohort 6: Four subjects will be administered a daily dose of 302 mg of MD-18 and two will receive placebo subcutaneously for 4 consecutive weeks. |
| The highest tolerated dose/dose-frequency identified in the first six cohorts | Experimental | Drug: MD-18, Drug: PlaceboCohort 7: Twelve non-diabetic obese subjects will be treated with the highest tolerated dose/dose-frequency identified in the first six cohorts and six subjects will be administered placebo. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects aged 18-70 years, both genders.
- BMI:
- HbA1c <6.5%
- Healthy as determined by a physician, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory function. History must comply with the following:
- Male subjects with female partners of childbearing potential must agree to utilize an approved contraceptive during the study.
Key exclusion criteria (22 listed)
- History of excessive alcohol use (defined as >21 drinks per week for males and >14 drinks per week for females), recreational drug use within the past three months, or failure on urinary drug screen. Note: use of Cannabinoids for medical purposes is allowed.
- Pregnant or breastfeeding within six months of screening assessment.
- Substantial changes in eating habits or exercise routine within the preceding three months.
- Evidence of eating disorders.
- >5% weight change in the past three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MD-18MD-18 administered subcutaneously to healthy individuals with overweight or obesity. | Drug | A daily dose of 302 mg of MD-18 or placebo for 4 consecutive weeks, A dose of 114 mg of MD-18 or placebo three times per week for 4 consecutive weeks, A dose of 227 mg of MD-18 or placebo three times per week for 4 consecutive weeks, A dose of 302 mg of MD-18 or placebo three times per week for 4 consecutive weeks, A dose of 74 mg of MD-18 or placebo three times per week for 4 consecutive weeks, A weekly dose of 302 mg of MD-18 or placebo for 4 consecutive weeks, The highest tolerated dose/dose-frequency identified in the first six cohorts |
| PlaceboPlacebo administered subcutaneously to healthy individuals with overweight or obesity. | Drug | A daily dose of 302 mg of MD-18 or placebo for 4 consecutive weeks, A dose of 114 mg of MD-18 or placebo three times per week for 4 consecutive weeks, A dose of 227 mg of MD-18 or placebo three times per week for 4 consecutive weeks, A dose of 302 mg of MD-18 or placebo three times per week for 4 consecutive weeks, A dose of 74 mg of MD-18 or placebo three times per week for 4 consecutive weeks, A weekly dose of 302 mg of MD-18 or placebo for 4 consecutive weeks, The highest tolerated dose/dose-frequency identified in the first six cohorts |
Primary outcome
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Adverse events.
Time frame: Through study completion, an average of 8 months
All adverse events, exacerbations of concomitant illnesses, or events known to be related to underlying disease processes or concomitant medications are to be recorded on the case report form throughout the study. Should there be more than 2 subjects receiving MD-18 with an adverse event grade 4 or 5 that is at least possibly related to MD-18, the study will be put on immediate hold and the data will be reviewed by the site Principal Investigator (PI) and the company Chief Medical Officer (CMO) before proceeding.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of body temperature.
Time frame: During the following study visits: Screening, Day 1,7,14,21,28 and 35) and at the study visits of the 8 weeks study extension period on days 42,56,70,84 and 92 (Only for subjects that have agreed to participate from Cohort 7)
Body temperature measurements in Celsius (°C) will be conllected at the visits specified in the study protocol's Schedule of Events. If any clinically significant findings or machine/equipment errors occur, the measurement will be repeated. Any confirmed clinically significant result will be recorded as adverse events (AEs).
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Serum chemistry.
Time frame: During the screening visit, Day 1, 7,28,35 and at the study visits of Day 56,84 and 92 at the 8 weeks study extension period (Only for subjects that have agreed to participate from Cohort 7).
Collection of blood samples for serum chemistry
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of body weight
Time frame: During each study visit and at the study visits of the 8 weeks study extension period (Only for subjects that have agreed to participate from Cohort 7)
Body weight (in kilograms) will be measured. To ensure consistency and accuracy, all subjects will be measured while wearing only undergarments or light clothing, without shoes. A calibrated scale will be used consistently throughout the study. In addition, weight measurements along with the screening height measurement will be combined to report BMI in kg/m^2
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Electrocardiogram examination.
Time frame: at screening (visit 1; Day -7) and days 7, 28 and 35. On Day 92 (for the 8 weeks extension period Only for subjects that have agreed to participate from Cohort 7).
12-lead triplicate ECGs will be obtained. The ECG machine will automatically calculate the following: Heart rate ( refers to the number of contractions of the heart per minute) PR interval (PR interval is the time from the beginning of the P wave (atrial depolarization) to the beginning of the QRS complex. QRS complex (represents the depolarization of ventricles And the beginning of systole and ventricular contraction). QT interval (is the time from the beginning of the QRS complex, representing ventricular depolarization, to the end of the T wave, resulting from ventricular repolarization). QTc interval (is the QT interval corrected for heart rate).
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of respiration rate
Time frame: During the following study visits: Screening, Day 1,7,14,21,28 and 35) and at the study visits of the 8 weeks study extension period on days 42,56,70,84 and 92 (Only for subjects that have agreed to participate from Cohort 7)
Respiration rate in breaths per minute will be collected at the visits specified in the study protocol's Schedule of Events. If any clinically significant findings or machine/equipment errors occur, the measurement will be repeated. Any confirmed clinically significant result will be recorded as adverse events.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of heart rate
Time frame: During the following study visits: Screening, Day 1,7,14,21,28 and 35) and at the study visits of the 8 weeks study extension period on days 42,56,70,84 and 92 (Only for subjects that have agreed to participate from Cohort 7)
Heart rate in beats per minute will be collected at the visits specified in the study protocol's Schedule of Events. If any clinically significant findings or machine/equipment errors occur, the measurement will be repeated. Any confirmed clinically significant result will be recorded as adverse events.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of systolic and diastolic blood pressure
Time frame: During the following study visits: Screening, Day 1,7,14,21,28 and 35) and at the study visits of the 8 weeks study extension period on days 42,56,70,84 and 92 (Only for subjects that have agreed to participate from Cohort 7)
Systolic and diastolic blood pressure in millimeters of mercury (mmHg) will be collected at the visits specified in the study protocol's Schedule of Events. If any clinically significant findings or machine/equipment errors occur, the measurement will be repeated. Any confirmed clinically significant result will be recorded as adverse events.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Hematology blood test
Time frame: During the screening visit, Day 1, 7,28,35 and at the study visits of Day 56,84 and 92 at the 8 weeks study extension period (Only for subjects that have agreed to participate from Cohort 7).
Collection of Hematology blood test
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of coagulation panel
Time frame: During the screening visit, Day 1, 7,28,35 and at the study visits of Day 56,84 and 92 at the 8 weeks study extension period (Only for subjects that have agreed to participate from Cohort 7).
Collection of blood samples for coagulation panel.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Urine analysis
Time frame: During the screening visit, Day 1, 7,28,35 and at the study visits of Day 56,84 and 92 at the 8 weeks study extension period (Only for subjects that have agreed to participate from Cohort 7).
Collection of urine samples for Urine analysis
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of height
Time frame: At the study screening visit (Day -28 to day -1 Pre-Treatment)
Height (in centimeters) will be collected only at the screening visit and will be combined with the body weight measurements in order to calculate the body mass index (BMI) in kg/m2. A calibrated scale will be used consistently throughout the study.
7 secondary outcomes
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of pharmacokinetic for Area Under the Curve (AUC) analysis
Time frame: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of pharmacokinetic for Maximum concentration of MD-18 (Cmax) analysis
Time frame: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of pharmacokinetic for Minimum concentration of MD-18 between doses (Cmin) analysis
Time frame: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Plasma samples for the pharmacokinetics analysis of Time to reach maximum concentration
Time frame: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of pharmacokinetic for the analysis of Half-life (t½)
Time frame: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Plasma samples for pharmacokinetics analysis of clearance rate (CL/F)
Time frame: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Plasma samples for the pharmacokinetics analysis of volume of distribution (V/F)
Time frame: Before dose administration and at 0.5, 1, 2, 4, and 8 hours after dose administration on Days 1 and 28 of each dose level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MD-18 in people with Healthy Volunteer, run by Cohen Global, Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety and tolerability multiple subcutaneous doses of MD-18 in overweight or obese but otherwise healthy subjects, as assessed by the collection of Adverse events. (time frame: Through study completion, an average of 8 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.