ObesityPhase 2NCT06259981
A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity
A Phase 2 study testing GLY-200 in people with Obesity, run by Glyscend, Inc. at 5 sites in United States.
Trial summary
This study will evaluate the efficacy, safety, and tolerability of GLY-200 in participants with obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- GLY-200
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 May 2024to 23 Oct 2024
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, ≥ 18 and ≤ 70 years old at the time of screening
- BMI ≥ 32 and ≤ 40 kg/m² at screening
Who cannot join
- Known history of any form of diabetes mellitus, or HbA1c ≥6.5% (48 mmol/mol)
- Participants who have had an increase or decrease in body weight more than 5% within the last 3 months
- Treated with any prescription medication or procedure that promotes weight loss or weight gain in the last 6 months
- Use of any drug treatment that affects gastric pH
- Use of any drug treatment that affects gastrointestinal motility
- Diagnosis or treatment of any symptomatic or structural abnormality of the GI tract or active disease within 12 months
- Clinically significant symptoms (as determined by the Investigator) of nausea, vomiting, bloating, diarrhea, flatulence, constipation, or abdominal pain in the last 30 days
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Mercury Street Medical
Butte, Montana, 59701
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761
Tandem Clinical Research
Marrero, Louisiana, 70072
Sensible Healthcare, LLC
Ocoee, Florida, 34761
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity
This study will evaluate the efficacy, safety, and tolerability of GLY-200 in participants with obesity.
Read the detailed description
This study is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study in adult participants with obesity. Approximately 70 participants will be randomized in a 1:1 ratio to GLY-200 (2.0 g, twice daily) or placebo (twice daily). There will be a ≤ 28-day screening period. Dosing will occur for 16 weeks. Clinic visits will occur at Screening, Week 0 (Day 1), and Weeks 1, 2, 4, 6, 8, 12, 16, and 17 [End of Study (EOS)] or Early Termination (ET). Phone visits will occur at Week 3, 10, and 14.
- Conditions
- Obesity
- Being tested
- GLY-200, Placebo
- Keywords
- Obesity, Glyscend, Inc., GLY-200
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLY-200Drug
2.0 g GLY-200 (4 x 0.5 g capsules) orally twice daily
PlaceboDrug
4 placebo capsules orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| GLY-200 | Experimental | Participants will receive 2.0 g GLY-200 orally twice daily for 16 weeks. Receives: Drug: GLY-200 |
| Placebo | Placebo comparator | Participants will receive placebo (identical in appearance to GLY-200) orally twice daily for 16 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in weight
Measured: Baseline and Week 16
Proportion of participants who achieve ≥ 5% body weight reduction
Measured: Baseline and Week 16
Secondary outcomes (3)
Change and percent change from baseline in weight
Measured: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline in waist circumference
Measured: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16
Incidence of adverse events (AEs) and serious adverse events (SAEs) considered by the Investigator to be related to study drug administration
Measured: Over the 16-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start20 May 2024
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glyscend, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Fineman, PhD, Study chair, Glyscend, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259981
- Sponsor's protocol ID
- GLY-200-03
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity
- ClinicalTrials.gov ID
- NCT06259981
- Acronym / sponsor ID
- GLY-200-03
- Conditions
- Obesity
- Keywords
- Obesity, Glyscend, Inc., GLY-200
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Glyscend, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 14 Feb 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.
This study will evaluate the efficacy, safety, and tolerability of GLY-200 in participants with obesity.
Detailed description
This study is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study in adult participants with obesity. Approximately 70 participants will be randomized in a 1:1 ratio to GLY-200 (2.0 g, twice daily) or placebo (twice daily). There will be a ≤ 28-day screening period. Dosing will occur for 16 weeks. Clinic visits will occur at Screening, Week 0 (Day 1), and Weeks 1, 2, 4, 6, 8, 12, 16, and 17 [End of Study (EOS)] or Early Termination (ET). Phone visits will occur at Week 3, 10, and 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLY-200 | Experimental | Drug: GLY-200Participants will receive 2.0 g GLY-200 orally twice daily for 16 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo (identical in appearance to GLY-200) orally twice daily for 16 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, ≥ 18 and ≤ 70 years old at the time of screening
- BMI ≥ 32 and ≤ 40 kg/m² at screening
Key exclusion criteria (7 listed)
- Known history of any form of diabetes mellitus, or HbA1c ≥6.5% (48 mmol/mol)
- Participants who have had an increase or decrease in body weight more than 5% within the last 3 months
- Treated with any prescription medication or procedure that promotes weight loss or weight gain in the last 6 months
- Use of any drug treatment that affects gastric pH
- Use of any drug treatment that affects gastrointestinal motility
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 |
|---|---|---|
| GLY-2002.0 g GLY-200 (4 x 0.5 g capsules) orally twice daily | Drug | GLY-200 |
| Placebo4 placebo capsules orally twice daily | Drug | Placebo |
Primary outcome
Percent change from baseline in weight
Time frame: Baseline and Week 16
Proportion of participants who achieve ≥ 5% body weight reduction
Time frame: Baseline and Week 16
3 secondary outcomes
Change and percent change from baseline in weight
Time frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline in waist circumference
Time frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16
Incidence of adverse events (AEs) and serious adverse events (SAEs) considered by the Investigator to be related to study drug administration
Time frame: Over the 16-week treatment period
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 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Mark Fineman, PhD study chair
Glyscend, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLY-200 in people with Obesity, run by Glyscend, Inc. at 5 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 2 inclusion and 7 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 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent change from baseline in weight (time frame: Baseline and Week 16). The study lists 2 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 Jan 2025; AzTrials last refreshed its copy on 3 Nov 2026.