ObesityPhase 1CAUSALITYNCT04663139
Xla1 Christensenella Minuta, Phase I, Randomized, Partially Placebo-controlled Double-blind Protocol, Evaluating Safety, Tolerability and Impact on the Gut Microbiota in Healthy Volunteers, Overweight and Obese Adults
A Phase 1 study testing Xla1 in people with Obesity and Metabolic Disease, run by YSOPIA Bioscience at 1 site in United States.
Trial summary
Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol, evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers, overweight and obese adults. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Disease
- What is being tested?
- Xla1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 26 Jun 2021
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or male
- Age between 19 and 65 years
- BMI between 18.5 and 24.9 kg/m²
- Good general and mental health state without clinically significant abnormalities in medical history, confirmed by physical examination
- Female subjects who are heterosexually active and of childbearing potential (e.g., not surgically sterile at least 6 months prior to first dose or naturally postmenopausal for at least 1 year prior to the first dose) must have been using one of the following forms of contraception and agree to continue using it through completion of the study:
- hormonal (e.g., oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to first dose,
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- double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to first dose,
- intrauterine device for at least 3 months prior to first dose, exclusive partner who has been vasectomized for at least 6 months (inclusive) prior to first dose.
- Female subjects of childbearing potential who are not currently engaging in heterosexual intercourse must agree to use one of the above methods of birth control, in the event that they have heterosexual intercourse during the course of the study (and until the final study visit) :
- Female subjects who are of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to first dose:
- hysteroscopic sterilization;
- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy;
- Transcervical sterilization or tubal occlusion (e.g., Essure® implantation)
- Be postmenopausal with amenorrhea for at least 1 year prior to first dose and FSH levels consistent with postmenopausal status as per the Investigator's judgment.
- Stable body weight for at least 3 months (fluctuation of less than 5% and no more than 4 kg)
- Agrees to keep food, drink, physical activities and alcohol consumption habits unchanged throughout the study
- Willing and able to comply with the protocol procedures, including feces processing.
- Female or male
- Age between 19 and 65 years, included.
- BMI between 25 and 35 kg/m², included
- Waist circumference > 94 cm for male (>90 cm for male of South-East Asian, Chinese and Japanese ethnic groups based on self reported ethnicity) and > 80 cm for female
- With at least ONE of the following untreated metabolic disorders related conditions:
- Triglycerides levels ≥ 1.5 g/L (1.71 mmol/L)
- HDL cholesterol levels <0.40 g/L (1.03 mmol/L) for male and <0.5 g/l (1.29 mmol/L) for female,
- Fasting plasma glucose ≥1 g/L (5.6 mmol/L)
- Female subjects who are heterosexually active and of childbearing potential (e.g., not surgically sterile at least 6 months prior to first dose or naturally postmenopausal for at least 1 year prior to the first dose) must have been using one of the following forms of contraception and agree to continue using it through completion of the study:
- hormonal (e.g., oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to first dose,
- double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to first dose,
- intrauterine device for at least 3 months prior to first dose, exclusive partner who has been vasectomized for at least 6 months (inclusive) prior to first dose.
- Female subjects of childbearing potential who are not currently engaging in heterosexual intercourse must agree to use one of the above methods of birth control, in the event that they have heterosexual intercourse during the course of the study (until the final study visit) :
- Female subjects who are of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to first dose:
- hysteroscopic sterilization;
- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy;
- Transcervical sterilization or tubal occlusion (e.g., Essure® implantation)
- Be postmenopausal with amenorrhea for at least 1 year prior to first dose and FSH levels consistent with postmenopausal status as per the Investigator's judgment.
- Stable body weight for at least 3 months (fluctuation of less than 5% and no more than 4 kg)
- Agrees to keep food, drink, physical activity and alcohol consumption habits unchanged throughout the study Willing and able to comply with the protocol procedures, including feces processing.
- An individual fulfilling ANY of the following criteria should be excluded from study enrollment:
- Exclusion Criteria for Healthy volunteers, Overweight and Obese patients (Part 1 and Part 2)
- Simultaneous participation in other clinical trials or previous participation within 30 days before randomization
- Any clinically confirmed congenital or acquired metabolic disorder incompatible with the conduct of the study by the investigator's opinion (including but not limited to: diabetes, hypothyroidism, familial hypercholesterolemia, etc.) Subjects with hypothyroidism on a stable dose of levothyroxine for at least 3 months and with a TSH in the normal range at screening may participate.
- Clinically significant cardiac, inflammatory, renal, gastrointestinal or cerebrovascular disorder, as judged by the investigator.
- Blood Pressure of ≥140/90 mmHg, Oral Temperature of ≥37.8°C, Pulse Rate of ≥100 bpm, at screening after 5 minutes of rest in the supine position. All screened subject with a blood pressure of ≥140/90 mmHg will be referred to their primary care physician.
- Medical history of any type of cancer except for squamous cell or basal cell skin carcinoma or uterine cervix carcinoma in situ treated surgically by local excision at least twenty-four weeks (6 months) prior to enrollment
- Major surgical procedure within the last 6 months or planned during the study
- Any history of Bariatric surgery
- Patients with a history of hypersensitivity to the investigational product or its excipients (Xla1 or placebo)
- Genetic obesity, i.e. obesity secondary to a genetic or medical condition, such as polycystic ovarian syndrome, hypothyroidism, Cushing's syndrome, growth hormone deficiency, insulinoma, hypothalamic disorders (e.g., Froelich syndrome, Bardet-Biedl syndrome, Prader-Willi syndrome), or use of any medication known to impact body weight within the last 6 months(e.g., antipsychotics).
- Clinically significant laboratory abnormalities as judged by the investigstor
- Patients with known positive serology for Human Immunodeficiency Virus - 1 or 2, Hepatitis B Virus or Hepatitis C Virus
- Pregnant or lactating women
- Concomitant treatment or medical history of treatment (in the last 6 months prior to enrollment) with drugs considered as acting on body weight such as:
- Anticonvulsants
- Anti-HIV therapy
- Anti-TNFα
- Anticoagulants
- FDA-approved obesity medications :
- Phentermine (Adipex, Suprenza) Diethylpropion (Tenuate) Phendimetrazine (Bontril PDM) Benzphetamine (Regimex Didrex) Orlistat (Xenical) Phentermine/Topiramate (Qysmia) Liraglutide (Saxenda) Naltrexone-bupropion (Contrave)
- Concomitant treatment or medical history of treatment (in the last 2 months prior to enrollment) with agents acting on gastrointestinal mobility (laxatives) irrespectively to the mode of action, antibiotics (oral, IM, IV)
- Less than 3 months from initiation of hormonal contraception, i.e. birth control pills, the contraceptive patch, vaginal ring, contraceptive implant, sustained release injectable hormone therapy, and hormonal intrauterine devices
- Significant changes in food habits or in physical activity within the last 6 months prior to enrollment
- Medical or personal history of eating disorder
- Consumption of more than 3 standard drinks of alcoholic beverage daily for men or 2 standard drinks daily for women (one drink is defined as 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of strong alcohol)
- Patients with a recent history (less than 2 years) of chronic excessive alcohol consumption (≥20g/daily) or clinical indication of alcohol abuse and dependence
- Recreational drugs consumption and/or substance use disorder within the past two years
- Current or former smokers, electronic cigarette smokers or users of any nicotine-based products (including Nicotine Replacement Therapy) for the period of 3 months prior to enrollment
- Person under legal protection (guardianship, wardship) or deprived from his/her rights following administrative or judicial decision
- Presenting a psychological or linguistic incapability to sign the informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol, evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers, overweight and obese adults. This study is designed as a FIH, Phase I, daily oral single dose, clinical trial evaluating safety, tolerability and the impact on the gut microbiota following introduction of Xla1 performed in 2 parts:
- Part 1: An open phase in normal weight healthy volunteers (HV) receiving all Xla1.
- Part 2: A randomized, parallel, double-blind, placebo-controlled phase in overweight or obese (stage 1) adult patients receiving either Xla1 or placebo.
Read the detailed description
Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol, evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers, overweight and obese adults. This study is designed as a FIH, Phase I, daily oral single dose, clinical trial evaluating safety, tolerability and the impact on the gut microbiota following introduction of Xla1 performed in 2 parts:
- Part 1: An open phase in normal weight healthy volunteers (HV) receiving all Xla1.
- Part 2: A randomized, parallel, double-blind, placebo-controlled phase in overweight or obese (stage 1) adult patients receiving either Xla1 or placebo.
The following objectives will be addressed in the program: 1) the primary objective of the study is to assess the safety and tolerability of Xla1 in Healthy adult Volunteers (HV) [part 1], and, subsequently, in overweight and Stage I obese adults [part 2]. 2) the secondary objectives comprise additional evaluation of the effects of Xla1 on subject's intestinal microbiome ecology and evaluation of the engraftment of Xla1 in the gastrointestinal tract (GIT).
- Conditions
- Obesity, Metabolic Disease
- Being tested
- Xla1, Placebo
- Keywords
- obesity, LBP, Xla1
- Medical subject headings
- Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xla1Drug
Xla1 is a Live Biotherapeutic Product (LBP) containing a strain of the bacteria Christensenella minuta (C. minuta)
PlaceboDrug
Also called Matching placebo
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| normal weight healthy adult volunteers receiving Xla1 | Experimental | one capsule Xla1 given once daily Receives: Drug: Xla1 |
| overweight and class 1 obese adult patients receiving Xla1 | Experimental | one capsule Xla1 given once daily Receives: Drug: Xla1 |
| overweight and class 1 obese adult patients receiving placebo | Placebo comparator | one capsule placebo given once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients experiencing adverse events
To assess the safety and tolerability of Xla1 in Healthy adult Volunteers (HV) [part 1], and, subsequently, in overweight and class I obese adults [part 2].
Measured: 12 weeks
Secondary outcomes (2)
Modulation of the gut microbiota composition
To evaluate the effects of Xla1 on subject's intestinal microbiome ecology
Measured: 12 weeks
Quantification of Xla1 presence in stools during the study
To evaluate the engraftment of Xla1 in the gastrointestinal tract (GIT)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Nov 2020
- Primary completion26 Jun 2021
- Study completion26 Jun 2021
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
- Model description
- This study is designed as a First in Human, Phase I, clinical trial evaluating safety, tolerability and the impact on the gut microbiota of Xla1. The study will be performed in 2 parts: Part 1: An open label phase in normal weight healthy adult volunteers receiving Xla1. Part 2: A randomized, parallel, double-blind, placebo-controlled phase I in overweight and class 1 obese adult patients receiving either Xla1 or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- YSOPIA Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663139
- Sponsor's protocol ID
- CAUSALITY
- Acronym
- CAUSALITY
- Status last verified
- Jul 2021
- First submitted
- 3 Dec 2020
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xla1 Christensenella Minuta, Phase I, Randomized, Partially Placebo-controlled Double-blind Protocol, Evaluating Safety, Tolerability and Impact on the Gut Microbiota in Healthy Volunteers, Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT04663139
- Acronym / sponsor ID
- CAUSALITY / CAUSALITY
- Conditions
- Obesity, Metabolic Disease
- Keywords
- obesity, LBP, Xla1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- YSOPIA BioscienceIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 26 Jun 2021 (actual)
- Study completion
- 26 Jun 2021 (actual)
- First posted
- 10 Dec 2020 (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.
Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol, evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers, overweight and obese adults. This study is designed as a FIH, Phase I, daily oral single dose, clinical trial evaluating safety, tolerability and the impact on the gut microbiota following introduction of Xla1 performed in 2 parts:
- Part 1: An open phase in normal weight healthy volunteers (HV) receiving all Xla1.
- Part 2: A randomized, parallel, double-blind, placebo-controlled phase in overweight or obese (stage 1) adult patients receiving either Xla1 or placebo.
Detailed description
Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol, evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers, overweight and obese adults. This study is designed as a FIH, Phase I, daily oral single dose, clinical trial evaluating safety, tolerability and the impact on the gut microbiota following introduction of Xla1 performed in 2 parts:
- Part 1: An open phase in normal weight healthy volunteers (HV) receiving all Xla1.
- Part 2: A randomized, parallel, double-blind, placebo-controlled phase in overweight or obese (stage 1) adult patients receiving either Xla1 or placebo.
The following objectives will be addressed in the program: 1) the primary objective of the study is to assess the safety and tolerability of Xla1 in Healthy adult Volunteers (HV) [part 1], and, subsequently, in overweight and Stage I obese adults [part 2]. 2) the secondary objectives comprise additional evaluation of the effects of Xla1 on subject's intestinal microbiome ecology and evaluation of the engraftment of Xla1 in the gastrointestinal tract (GIT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is designed as a First in Human, Phase I, clinical trial evaluating safety, tolerability and the impact on the gut microbiota of Xla1. The study will be performed in 2 parts: Part 1: An open label phase in normal weight healthy adult volunteers receiving Xla1. Part 2: A randomized, parallel, double-blind, placebo-controlled phase I in overweight and class 1 obese adult patients receiving either Xla1 or placebo.
| Arm | Type | Receives |
|---|---|---|
| normal weight healthy adult volunteers receiving Xla1 | Experimental | Drug: Xla1one capsule Xla1 given once daily |
| overweight and class 1 obese adult patients receiving Xla1 | Experimental | Drug: Xla1one capsule Xla1 given once daily |
| overweight and class 1 obese adult patients receiving placebo | Placebo comparator | Drug: Placeboone capsule placebo given once daily |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (72 listed)
- Female or male
- Age between 19 and 65 years
- BMI between 18.5 and 24.9 kg/m²
- Good general and mental health state without clinically significant abnormalities in medical history, confirmed by physical examination
- Female subjects who are heterosexually active and of childbearing potential (e.g., not surgically sterile at least 6 months prior to first dose or naturally postmenopausal for at least 1 year prior to the first dose) must have been using one of the following forms of contraception and agree to continue using it through completion of the study:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Xla1Xla1 is a Live Biotherapeutic Product (LBP) containing a strain of the bacteria Christensenella minuta (C. minuta) | Drug | normal weight healthy adult volunteers receiving Xla1, overweight and class 1 obese adult patients receiving Xla1 |
| PlaceboAlso: Matching placeboMatching placebo | Drug | overweight and class 1 obese adult patients receiving placebo |
Primary outcome
number of patients experiencing adverse events
Time frame: 12 weeks
To assess the safety and tolerability of Xla1 in Healthy adult Volunteers (HV) [part 1], and, subsequently, in overweight and class I obese adults [part 2].
2 secondary outcomes
Modulation of the gut microbiota composition
Time frame: 12 weeks
Quantification of Xla1 presence in stools during the study
Time frame: 12 weeks
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 13 Jul 2021.
- 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 Xla1 in people with Obesity and Metabolic Disease, run by YSOPIA Bioscience at 1 site 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 72 inclusion and 0 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 13 Jul 2021. 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 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 patients experiencing adverse events (time frame: 12 weeks). 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 13 Jul 2021.