ObesityPhase 1NCT03625778
A Study to Assess Safety, Tolerability, and Pharmacokinetics of MEDI0382 in Non-diabetic Obese Participants
A Phase 1 study testing MEDI0382 in people with Obesity, run by MedImmune LLC at 2 sites in United States.
Trial summary
This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51 non-diabetic obese participants with a body mass index (BMI) ≥ 35 kg/m^2. The participants will be observed among 3 separate cohorts and participate in the study for up to approximately 27 weeks, including a screening period… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- MEDI0382
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Aug 2018to 25 Aug 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- Male and female participants age 18 through 65 years
- BMI ≥ 35 kg/m^2
- Hemoglobin A1c level of < 6.5%
- Female participants must have a negative pregnancy test and must not be lactating.
- Females of childbearing potential using appropriate birth control to avoid pregnancy during the study.
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- Stable body weight
- Willing and able to adhere to the visit/protocol schedule, including following lifestyle advice with respect to diet and exercise for the duration of the study
- Willing and able to self-administer daily SC injections following an initial self-injection training
Who cannot join
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to Study Day 1 dosing.
- Any condition that, in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of participants safety or study results.
- Active participation in any other investigation clinical study.
- Any prescription or non-prescription drugs for weight loss including herbal or other dietary supplements used within the past 3 months prior to screening.
- Previous glucagon-like peptide-1 (GLP-1) use within 3 months prior to screening.
- Any positive results for serum hepatitis B surface antigen, hepatitis C virus antibody and/or human immunodeficiency virus (HIV) antibody at screening.
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- Laboratory tests results as specified in the protocol (laboratory tests may be repeated once for confirmation of out of range values at screening).
- Significant hepatic or renal impairment
- Poorly controlled hypertension
- Known or suspected history of drug or alcohol abuse within the past year or positive current test
- Previous surgical procedures for weight loss
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Dallas, Texas, 75247
Research Site
Daytona Beach, Florida, 32117
About this study
Official title: A Randomized, Blinded, Placebo-controlled Study to Assess Pharmacokinetics, Safety, and Tolerability of Ascending Doses of MEDI0382 in Non-diabetic Obese Subjects
This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51 non-diabetic obese participants with a body mass index (BMI) ≥ 35 kg/m^2. The participants will be observed among 3 separate cohorts and participate in the study for up to approximately 27 weeks, including a screening period (including a run-in), treatment period, and safety follow-up.
Read the detailed description
This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51 non-diabetic obese participants with a BMI ≥ 35 kg/m2. Participants will be blinded, but investigators/site staff and sponsor will be unblinded for Cohort 1. In Cohorts 2 and 3 participants, investigators, and contract research organization personnel are blinded to investigational product and sponsor is unblinded. The participants will participate in the study for up to approximately 27 weeks, including a screening period (including a run-in), treatment period, and safety follow-up.
Participants will be randomized 4:1 to MEDI0382 (n=12) or placebo (n=3) for Cohort 1 and randomized 2:1 to MEDI0382 (n=12) or placebo (n=6) for Cohorts 2 and 3. In Cohort 1 participants randomized to MEDI0382 or placebo will be dosed daily with a weekly titration schedule until the highest clinically tolerated dose (CTD) is established. In Cohort 2 participants randomized to MEDI0382 or placebo will be dosed daily with a 2 week titration schedule up to the highest CTD is established in Cohort 1. In Cohort 3 participants randomized to MEDI0382 or placebo will be dosed daily with a 4 week participants schedule up to the highest CTD established in Cohort 1. Once the highest CTD is identified, participants will continue on the highest CTD for an additional 2 weeks of treatment for Cohort 1 and 3 and additional 4 weeks treatment for Cohort 2. All participants will return 28 days post last dose for a safety follow-up visit.
- Conditions
- Obesity
- Being tested
- MEDI0382, Placebo
- Keywords
- Obesity, MEDI0382, Overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI0382Drug
Also called Cotadutide
MEDI0382 will be administered subcutaneously daily according to the MEDI0382 cohorts.
PlaceboDrug
Placebo will be administered subcutaneously daily according to the Placebo cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Cohort 1 | Placebo comparator | Participants will receive subcutaneous (SC) placebo matched to MEDI0382 Cohort 1 once daily for 9 weeks. Receives: Drug: Placebo |
| MEDI0382 Cohort 1 | Experimental | Participants will receive SC MEDI0382 titrated doses of Dose 1 to 7 once daily (7-step titration/ 1 week per dose) from Weeks 1 to 7 followed by additional treatment of SC MEDI0382 Dose 7 once daily from Weeks 7 to 9. Receives: Drug: MEDI0382 |
| Placebo Cohort 2 | Placebo comparator | Participants will receive SC placebo matched to MEDI0382 Cohort 2 once daily for 14 weeks. Receives: Drug: Placebo |
| MEDI0382 Cohort 2 | Experimental | Participants will receive SC MEDI0382 titrated doses of Doses 1, 2, 3, 5, and 7 once daily (5-step titration/ 2 week per dose) from Weeks 1 to 10 followed by additional treatment of SC MEDI0382 Dose 7 once daily from Weeks 11 to 14. Receives: Drug: MEDI0382 |
| Placebo Cohort 3 | Placebo comparator | Participants will receive SC placebo matched to MEDI0382 Cohort 3 once daily for 18 weeks. Receives: Drug: Placebo |
| MEDI0382 Cohort 3 | Experimental | Participants will receive SC MEDI0382 titrated doses of Doses 1, 8, 4, and 7 once daily (4-step titration/ 4 week per dose) from Weeks 1 to 16 followed by additional treatment of SC MEDI0382 Dose 7 once daily from Weeks 17 to 18. Receives: Drug: MEDI0382 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) for Cohorts 1, 2, and 3
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Measured: From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs for Cohorts 1, 2, and 3
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters were defined as any abnormal finding during analysis of hematology, clinical chemistry, and urinalysis.
Measured: From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs for Cohorts 1, 2, and 3
Number of participants with abnormal vital signs (body temperature, blood pressure, heart rate, and respiratory rate) and physical examinations reported as TEAEs are reported.
Measured: From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs for Cohorts 1, 2, and 3
Number of participants with abnormal ECG parameters reported as TEAEs are reported.
Measured: From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)
Change in Blood Pressure from Baseline to End of Dosing as Measured by Telemetry for Cohort 1
Telemetry is the process of recording and transmitting the vital readings (temperature, blood pressure, pulse rate, and respiratory rate). It is used to continuously monitor vital reading as a real-time safety measure. Mean change in blood pressure from baseline to end of dosing measured by telemetry for Cohort 1 are reported.
Measured: From Baseline (Day -1) through end of dosing (Day 63)
Change in Respiratory Rate from Baseline to End of Dosing as Measured by Telemetry for Cohort 1
Telemetry is the process of recording and transmitting the vital readings (temperature, blood pressure, pulse rate, and respiratory rate). It is used to continuously monitor vital reading as a real-time safety measure. Mean change in respiratory rate from baseline to end of dosing measured by telemetry for Cohort 1 are reported.
Measured: From Baseline (Day -1) through end of dosing (Day 63)
Change in Pulse Rate from Baseline to End of Dosing as Measured by Telemetry for Cohort 1
Telemetry is the process of recording and transmitting the vital readings (temperature, blood pressure, pulse rate, and respiratory rate). It is used to continuously monitor vital reading as a real-time safety measure. Mean change in pulse rate from baseline to end of dosing measured by telemetry for Cohort 1 are reported.
Measured: From Baseline (Day -1) through end of dosing (Day 63)
Change in Temperature from Baseline to End of Dosing as Measured by Telemetry for Cohort 1
Telemetry is the process of recording and transmitting the vital readings (temperature, blood pressure, pulse rate, and respiratory rate). It is used to continuously monitor vital reading as a real-time safety measure. Mean change in temperature from baseline to end of dosing measured by telemetry for Cohort 1 are reported.
Measured: From Baseline (Day -1) through end of dosing ( Day 63)
Secondary outcomes (9)
Maximum Observed Plasma Concentration (Cmax) of MEDI0382 for Cohort 1
The Cmax of MEDI0382 (Cotadutide) for MEDI0382 Doses 1 to 7 for Cohort 1 are reported.
Measured: Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Days 7, 14, 21, 28, 35, 42, and 49 for MEDI0382 Doses 1 to 7, respectively
Cmax of MEDI0382 Dose 1 on Day 1 for Cohort 1
The Cmax of MEDI0382 Dose 1 for Cohort 1 is reported.
Measured: Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1
Area Under the Concentration-time Curve at the end of the Dosing interval (AUCτ) of MEDI0382 for Cohort 1
The AUCτ of MEDI0382 for MEDI0382 Doses 1 to 7 for Cohort 1 are reported.
Measured: Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Days 7, 14, 21, 28, 35, 42, and 49 for MEDI0382 Doses 1 to 7, respectively
AUCτ of MEDI0382 Dose 1 on Day 1 for Cohort 1
The AUCτ of MEDI0382 Dose 1 for Cohort 1 is reported.
Measured: Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1
Time to Maximum Observed Plasma Concentration (Tmax) of MEDI0382 for Cohort 1
The Tmax of MEDI0382 for MEDI0382 Doses 1 to 7 for Cohort 1 are reported.
Measured: Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Days 7, 14, 21, 28, 35, 42, and 49 for MEDI0382 Doses 1 to 7, respectively
Tmax of MEDI0382 Dose 1 on Day 1 for Cohort 1
The Tmax of MEDI0382 Dose 1 for Cohort 1 is reported.
Measured: Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1
Plasma Concentration of MEDI0382 for Cohorts 2 and 3
Plasma concentration of MEDI0382 for predose and 6 hours postdose for Cohorts 2 and 3 are reported.
Measured: Cohort 2: predose and 6 hours postdose on Days 1, 15, 29, 43, and 57 for MEDI0382 Doses 1, 2, 3, 5, and 7, respectively; Cohort 3: predose and 6 hours postdose on Days 1, 29, 57, and 85 for MEDI0382 Doses 1, 8, 4, and 7, respectively
Plasma Concentration of MEDI0382 Dose 7 on Day 71 for Cohort 2 and MEDI0382 Dose 7 on Day 113 for Cohort 3
Plasma concentration of MEDI0382 Dose 7 for predose and 6 hours postdose on Day 71 for Cohort 2 and on Day 113 for Cohort 3 are reported.
Measured: Cohort 2: predose and 6 hours postdose on Day 71 for MEDI0382 Dose 7; Cohort 3: predose and 6 hours postdose on Day 113 for MEDI0382 Dose 7
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI0382 in all Cohorts
Number of participants with positive ADA to MEDI0382 are reported.
Measured: Predose on Baseline (Day -1) and follow-up visit (28 days after the last dose) for each cohort; predose on Days 28 and 50 for Cohort 1, on Days 7, 28, 71, 98 for Cohort 2, and on Days 7, 28, 71, 126 for Cohort 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start14 Aug 2018
- Primary completion25 Aug 2019
- Study completion25 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625778
- Sponsor's protocol ID
- D5672C00001
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2018
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Placebo-controlled Study to Assess Pharmacokinetics, Safety, and Tolerability of Ascending Doses of MEDI0382 in Non-diabetic Obese Subjects
- ClinicalTrials.gov ID
- NCT03625778
- Acronym / sponsor ID
- D5672C00001
- Conditions
- Obesity
- Keywords
- Obesity, MEDI0382, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 25 Aug 2019 (actual)
- Study completion
- 25 Aug 2019 (actual)
- First posted
- 10 Aug 2018 (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.
This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51 non-diabetic obese participants with a body mass index (BMI) ≥ 35 kg/m^2. The participants will be observed among 3 separate cohorts and participate in the study for up to approximately 27 weeks, including a screening period (including a run-in), treatment period, and safety follow-up.
Detailed description
This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51 non-diabetic obese participants with a BMI ≥ 35 kg/m2. Participants will be blinded, but investigators/site staff and sponsor will be unblinded for Cohort 1. In Cohorts 2 and 3 participants, investigators, and contract research organization personnel are blinded to investigational product and sponsor is unblinded. The participants will participate in the study for up to approximately 27 weeks, including a screening period (including a run-in), treatment period, and safety follow-up.
Participants will be randomized 4:1 to MEDI0382 (n=12) or placebo (n=3) for Cohort 1 and randomized 2:1 to MEDI0382 (n=12) or placebo (n=6) for Cohorts 2 and 3. In Cohort 1 participants randomized to MEDI0382 or placebo will be dosed daily with a weekly titration schedule until the highest clinically tolerated dose (CTD) is established. In Cohort 2 participants randomized to MEDI0382 or placebo will be dosed daily with a 2 week titration schedule up to the highest CTD is established in Cohort 1. In Cohort 3 participants randomized to MEDI0382 or placebo will be dosed daily with a 4 week participants schedule up to the highest CTD established in Cohort 1. Once the highest CTD is identified, participants will continue on the highest CTD for an additional 2 weeks of treatment for Cohort 1 and 3 and additional 4 weeks treatment for Cohort 2. All participants will return 28 days post last dose for a safety follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo Cohort 1 | Placebo comparator | Drug: PlaceboParticipants will receive subcutaneous (SC) placebo matched to MEDI0382 Cohort 1 once daily for 9 weeks. |
| MEDI0382 Cohort 1 | Experimental | Drug: MEDI0382Participants will receive SC MEDI0382 titrated doses of Dose 1 to 7 once daily (7-step titration/ 1 week per dose) from Weeks 1 to 7 followed by additional treatment of SC MEDI0382 Dose 7 once daily from Weeks 7 to 9. |
| Placebo Cohort 2 | Placebo comparator | Drug: PlaceboParticipants will receive SC placebo matched to MEDI0382 Cohort 2 once daily for 14 weeks. |
| MEDI0382 Cohort 2 | Experimental | Drug: MEDI0382Participants will receive SC MEDI0382 titrated doses of Doses 1, 2, 3, 5, and 7 once daily (5-step titration/ 2 week per dose) from Weeks 1 to 10 followed by additional treatment of SC MEDI0382 Dose 7 once daily from Weeks 11 to 14. |
| Placebo Cohort 3 | Placebo comparator | Drug: PlaceboParticipants will receive SC placebo matched to MEDI0382 Cohort 3 once daily for 18 weeks. |
| MEDI0382 Cohort 3 | Experimental | Drug: MEDI0382Participants will receive SC MEDI0382 titrated doses of Doses 1, 8, 4, and 7 once daily (4-step titration/ 4 week per dose) from Weeks 1 to 16 followed by additional treatment of SC MEDI0382 Dose 7 once daily from Weeks 17 to 18. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of written informed consent
- Male and female participants age 18 through 65 years
- BMI ≥ 35 kg/m^2
- Hemoglobin A1c level of < 6.5%
- Female participants must have a negative pregnancy test and must not be lactating.
Key exclusion criteria (11 listed)
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to Study Day 1 dosing.
- Any condition that, in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of participants safety or study results.
- Active participation in any other investigation clinical study.
- Any prescription or non-prescription drugs for weight loss including herbal or other dietary supplements used within the past 3 months prior to screening.
- Previous glucagon-like peptide-1 (GLP-1) use within 3 months prior to screening.
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 |
|---|---|---|
| MEDI0382Also: CotadutideMEDI0382 will be administered subcutaneously daily according to the MEDI0382 cohorts. | Drug | MEDI0382 Cohort 1, MEDI0382 Cohort 2, MEDI0382 Cohort 3 |
| PlaceboPlacebo will be administered subcutaneously daily according to the Placebo cohorts. | Drug | Placebo Cohort 1, Placebo Cohort 2, Placebo Cohort 3 |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) for Cohorts 1, 2, and 3
Time frame: From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs for Cohorts 1, 2, and 3
Time frame: From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters were defined as any abnormal finding during analysis of hematology, clinical chemistry, and urinalysis.
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs for Cohorts 1, 2, and 3
Time frame: From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)
Number of participants with abnormal vital signs (body temperature, blood pressure, heart rate, and respiratory rate) and physical examinations reported as TEAEs are reported.
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs for Cohorts 1, 2, and 3
Time frame: From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)
Number of participants with abnormal ECG parameters reported as TEAEs are reported.
Change in Blood Pressure from Baseline to End of Dosing as Measured by Telemetry for Cohort 1
Time frame: From Baseline (Day -1) through end of dosing (Day 63)
Telemetry is the process of recording and transmitting the vital readings (temperature, blood pressure, pulse rate, and respiratory rate). It is used to continuously monitor vital reading as a real-time safety measure. Mean change in blood pressure from baseline to end of dosing measured by telemetry for Cohort 1 are reported.
Change in Respiratory Rate from Baseline to End of Dosing as Measured by Telemetry for Cohort 1
Time frame: From Baseline (Day -1) through end of dosing (Day 63)
Telemetry is the process of recording and transmitting the vital readings (temperature, blood pressure, pulse rate, and respiratory rate). It is used to continuously monitor vital reading as a real-time safety measure. Mean change in respiratory rate from baseline to end of dosing measured by telemetry for Cohort 1 are reported.
Change in Pulse Rate from Baseline to End of Dosing as Measured by Telemetry for Cohort 1
Time frame: From Baseline (Day -1) through end of dosing (Day 63)
Telemetry is the process of recording and transmitting the vital readings (temperature, blood pressure, pulse rate, and respiratory rate). It is used to continuously monitor vital reading as a real-time safety measure. Mean change in pulse rate from baseline to end of dosing measured by telemetry for Cohort 1 are reported.
Change in Temperature from Baseline to End of Dosing as Measured by Telemetry for Cohort 1
Time frame: From Baseline (Day -1) through end of dosing ( Day 63)
Telemetry is the process of recording and transmitting the vital readings (temperature, blood pressure, pulse rate, and respiratory rate). It is used to continuously monitor vital reading as a real-time safety measure. Mean change in temperature from baseline to end of dosing measured by telemetry for Cohort 1 are reported.
9 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of MEDI0382 for Cohort 1
Time frame: Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Days 7, 14, 21, 28, 35, 42, and 49 for MEDI0382 Doses 1 to 7, respectively
Cmax of MEDI0382 Dose 1 on Day 1 for Cohort 1
Time frame: Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1
Area Under the Concentration-time Curve at the end of the Dosing interval (AUCτ) of MEDI0382 for Cohort 1
Time frame: Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Days 7, 14, 21, 28, 35, 42, and 49 for MEDI0382 Doses 1 to 7, respectively
AUCτ of MEDI0382 Dose 1 on Day 1 for Cohort 1
Time frame: Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1
Time to Maximum Observed Plasma Concentration (Tmax) of MEDI0382 for Cohort 1
Time frame: Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Days 7, 14, 21, 28, 35, 42, and 49 for MEDI0382 Doses 1 to 7, respectively
Tmax of MEDI0382 Dose 1 on Day 1 for Cohort 1
Time frame: Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1
Plasma Concentration of MEDI0382 for Cohorts 2 and 3
Time frame: Cohort 2: predose and 6 hours postdose on Days 1, 15, 29, 43, and 57 for MEDI0382 Doses 1, 2, 3, 5, and 7, respectively; Cohort 3: predose and 6 hours postdose on Days 1, 29, 57, and 85 for MEDI0382 Doses 1, 8, 4, and 7, respectively
Plasma Concentration of MEDI0382 Dose 7 on Day 71 for Cohort 2 and MEDI0382 Dose 7 on Day 113 for Cohort 3
Time frame: Cohort 2: predose and 6 hours postdose on Day 71 for MEDI0382 Dose 7; Cohort 3: predose and 6 hours postdose on Day 113 for MEDI0382 Dose 7
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI0382 in all Cohorts
Time frame: Predose on Baseline (Day -1) and follow-up visit (28 days after the last dose) for each cohort; predose on Days 28 and 50 for Cohort 1, on Days 7, 28, 71, 98 for Cohort 2, and on Days 7, 28, 71, 126 for Cohort 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Results of this clinical trial are available on www.astrazenecaclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI0382 in people with Obesity, run by MedImmune LLC at 2 sites in United States.
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 9 inclusion and 11 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: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) for Cohorts 1, 2, and 3 (time frame: From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)). The study lists 8 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 23 Aug 2021.