Overweight , ObesityPhase 2PRESERVENCT07837973
Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss
A Phase 2 study testing ALV-100 in people with Overweight , Obesity and Adults, run by Alveus Therapeutics, Inc. at 20 sites in United States.
Trial summary
A study of ALV-100 to assess efficacy, safety and tolerability among participants with overweight or obesity who have previously achieved a body weight reduction of ≥10% while treated with incretin-based therapies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight , Obesity, Adults
- What is being tested?
- ALV-100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 20 sitesUnited States
- Study dates
- 10 Aug 2026to 24 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female participants, aged ≥18 to ≤75
- BMI ≥23 kg/m2 at screening.
- Has been treated with incretin-based therapy for weight management at a stable dose for at least 3 continuous months prior to screening.
- Tolerating incretin-based therapy at the discretion of the investigator
- WL of at least 10% while on incretin-based therapy and with stable BW for at least 3 months prior to screening.
- Willing to maintain their current general diet and physical activity regimen throughout the study.
Who cannot join
- Lifetime history of Type 1 or Type 2 diabetes
- Prior obesity treatment with surgery or a weight loss device.
- Obesity caused by known endocrinologic disorders or by known congenital or acquired hypothalamic disease or monogenetic or syndromic forms of obesity.
- Current or history of (within 3 months prior to screening) treatment with medications that may cause significant weight gain.
- Family or personal history of MTC or MEN 2
- Presence or history of malignant neoplasms within the past 5 years prior to screening
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
University of Alabama - Birmingham
Birmingham, Alabama, 35294
Shruti Sukhanandi, 205-934-4980, sbsukhan@uab.edu
Garvey, MD
- Recruiting
DM Clinical Research
Bradenton, Florida, 34209
Principal Investigator, 407-508-8249, jeremy.mcconnell@dmclinical.com
Jeremy McConnell, MD
- Recruiting
Christie Clinic
Champaign, Illinois, 61822
Sarah Berlatsky, 217-366-4003, slberlatsky@christieclinic.com
McCormick, DO
- Recruiting
DM Clinical Research
Doral, Florida, 33166
Principal Investigator, 786-789-1036 ext. 2605, noreen.shaaban@dmclinical.com
Noreen Shaaban, MD
- Recruiting
Profound Research
Farmington Hills, Michigan, 48334
Recruitment Lead, 248-282-3640, recruitmentleads@profoundresearch.com
Schmeltz, MD
- Recruiting
BRCR Global Louisiana
Gretna, Louisiana, 70053
Fernando Del Angel, 561-447-0614 ext. 300, fdelangel@brcrglobal.com
Nguyen, MD
- Recruiting
DM Clinical Research
Irving, Texas, 75063
Steven Galvan, 214-304-7491, steven.galvan@dmclinical.com
Alibhai, MD
- Recruiting
AMR Clinical
Nashville, Tennessee, 37203
John Viselli, 615-334-9150, john.viselli@amr-clinical.com
Bowles, MD, PC
- Recruiting
ALSA Research-Manhattan
New York, New York, 10016
ALSA Research-Manhattan, 646-395-8175, sstein@alsaresearch.com
Bhatt, MD
- Recruiting
Profound Research
Oceanside, California, 92058
Christina Spencer, 760-826-2020, Christina.Spencer@profoundresearch.com
Lizotte, DO
- Recruiting
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73106
Lacey Dietz, 405-602-3939 ext. 118, ldietz@lhsi.net
Griffin, MD
- Recruiting
Clinical Neuroscience Solutions
Orlando, Florida, 32801
Marla Graddic, 407-425-5100, marla.graddic@cnshealthcare.com
Miroshnikova, MD
- Recruiting
DM Clinical Research - Dominion Family Healthcare
San Antonio, Texas, 78257
Principal Investigator, 830-283-7997, rashid.atique@dmclinical.com
Rashid Atique, MD
- Recruiting
Tekton Research
San Antonio, Texas, 78258
Jillian Reynolds, 210-996-2600, jillian.reynolds@tektonresearch.com
McDonald, MD
- Recruiting
AMR Clinical
South Jordan, Utah, 84095
Kate Aragundi, 801-500-3399, Kate.aragundi@amr-clinical.com
Andrews, DO
- Recruiting
DM Clinical Research
Sun City, Arizona, 85373
Katrina Spencer, MD, 602-325-1553, Katrina.Spencer@dmclinical.com
Mahadevan, MD
- Recruiting
AMR Clinical
Tempe, Arizona, 85281
Sandy Quintanilla, 602-910-3343, sandy.quintanilla@amr-clinical.com
Reedy, MD
- Recruiting
DM Clinical Research
Tomball, Texas, 77375
Lyannah Contreras, 346-426-8749, Lyannah.Contreras@dmclinical.com
Ifran, MD
- Recruiting
TMA Headlands
Wilmington, North Carolina, 28403
Megan Crouch, 910-406-2268, megan.crouch@headlandsresearch.com
Jones, MD
- Recruiting
North Georgia Clinical Research
Woodstock, Georgia, 30189
Principal Investigator, 678-494-5735, bram.wieskopf@ngclinicalresearch.com
Bram Weiskopf, MD
About this study
Official title: A Double-Blind, Randomized, Multi-Center, Dose-Ranging, Phase 2 Study of the Efficacy and Safety of ALV-100 Versus Placebo for Maintenance of Weight Loss in Patients Previously Treated With Incretin-Based Therapies
A study of ALV-100 to assess efficacy, safety and tolerability among participants with overweight or obesity who have previously achieved a body weight reduction of ≥10% while treated with incretin-based therapies.
- Conditions
- Overweight , Obesity, Adults
- Being tested
- ALV-100, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALV-100Drug
Experimental drug
PlaceboDrug
Volume matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose A - Schedule 1 | Experimental | Participants will receive ALV-100 or volume matched placebo during the treatment period Receives: Drug: ALV-100; Drug: Placebo |
| Dose B - Schedule 1 | Experimental | Participants will receive ALV-100 or volume matched placebo during the treatment period Receives: Drug: ALV-100; Drug: Placebo |
| Dose C - Schedule 1 | Experimental | Participants will receive ALV-100 or volume matched placebo during the treatment period Receives: Drug: ALV-100; Drug: Placebo |
| Dose A - Schedule 2 | Experimental | Participants will receive ALV-100 or volume matched placebo during the treatment period Receives: Drug: ALV-100; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose response of ALV-100 as assessed by maintenance of weight loss
Percentage change from baseline to Week 24 in BW
Measured: 24 weeks
Secondary outcomes (8)
Assess the safety and tolerability of ALV-100
Incidence of treatment emergent adverse events (TEAE) from first dose administration until Week 36
Measured: 36 weeks
Efficacy of ALV-100 compared to placebo as assessed by maintenance of weight loss
Percentage change from baseline to week 24 and to Week 36 in Body Weight. Change from baseline to Week 24 and to Week 36 in BW (kg). Participants with a percentage change in BW from baseline to week 24 and to Week 36 of ≤3 %
Measured: 24-36 weeks
Change from baseline in glycemic control parameters
Change from baseline in fasting glucose and hemoglobin A1c (HbA1c). Fasting glucose will be measured in mg/dL or mmol/L and HbA1c will be measured as percentage (%) or mmol/mol.
Measured: 24-36 weeks
Change from baseline in lipid parameters
Change from baseline in total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-cholesterol, VLDL-cholesterol, triglycerides, and free fatty acids (FFA), measured in mg/dL or mmol/L.
Measured: 24-36 weeks
Change from baseline in vital signs
Change from baseline in systolic and diastolic blood pressure, measured in mmHg.
Measured: 24-36 weeks
Immunogenicity of ALV-100
Incidence of anti-drug antibodies (ADA) from baseline (pre-dose) until Week 36
Measured: 36 weeks
Efficacy of ALV-100 versus placebo on subjective control of eating, food cravings, and mood-related eating behaviors as assessed by the Control of Eating Questionnaire (CoEQ)
Change from baseline in total and subscale scores of the Control of Eating Questionnaire (CoEQ) which is a 19-item patient-reported outcome measure that assesses aspects of eating behavior, including hunger, satiety, food cravings, craving control, and mood. Items are rated on an 11-point numeric rating scale from 0 to 10. The CoEQ includes four subscales: Craving Control (5 items), Positive Mood (4 items), Craving for Sweet Foods (4 items), and Craving for Savoury Foods (4 items), as well as single-item assessments of hunger and satiety. Subscale scores are calculated as the mean of the applicable item scores and range from 0 to 10. Higher Craving Control scores indicate greater control over food cravings, while higher craving scores indicate greater food cravings.
Measured: 24-36 weeks
Effect of ALV-100 vs. placebo on food noise as assessed by the Food Noise Questionnaire (FNQ)
Change from baseline in total scores of the FOOD Noise Questionnaire (FNQ). The Food Noise Questionnaire (FNQ) is a 5-item patient-reported outcome measure designed to assess persistent and intrusive thoughts about food that may interfere with daily life. Each item is rated on a 5-point Likert scale from 0 (strongly disagree) to 4 (strongly agree). The total score is calculated by summing the responses to the 5 items and ranges from 0 to 20. Higher scores indicate greater levels of food noise.
Measured: 24-36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start10 Aug 2026
- Primary completion24 Aug 2027 (estimated)
- Study completion24 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alveus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837973
- Sponsor's protocol ID
- ALV-101-1
- Acronym
- PRESERVE
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Multi-Center, Dose-Ranging, Phase 2 Study of the Efficacy and Safety of ALV-100 Versus Placebo for Maintenance of Weight Loss in Patients Previously Treated With Incretin-Based Therapies
- ClinicalTrials.gov ID
- NCT07837973
- Acronym / sponsor ID
- PRESERVE / ALV-101-1
- Conditions
- Overweight , Obesity, Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Alveus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 24 Aug 2027 (estimated)
- Study completion
- 24 Aug 2027 (estimated)
- First posted
- 24 Sep 2026 (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 study of ALV-100 to assess efficacy, safety and tolerability among participants with overweight or obesity who have previously achieved a body weight reduction of ≥10% while treated with incretin-based therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose A - Schedule 1 | Experimental | Drug: ALV-100, Drug: PlaceboParticipants will receive ALV-100 or volume matched placebo during the treatment period |
| Dose B - Schedule 1 | Experimental | Drug: ALV-100, Drug: PlaceboParticipants will receive ALV-100 or volume matched placebo during the treatment period |
| Dose C - Schedule 1 | Experimental | Drug: ALV-100, Drug: PlaceboParticipants will receive ALV-100 or volume matched placebo during the treatment period |
| Dose A - Schedule 2 | Experimental | Drug: ALV-100, Drug: PlaceboParticipants will receive ALV-100 or volume matched placebo during the treatment period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male and female participants, aged ≥18 to ≤75
- BMI ≥23 kg/m2 at screening.
- Has been treated with incretin-based therapy for weight management at a stable dose for at least 3 continuous months prior to screening.
- Tolerating incretin-based therapy at the discretion of the investigator
- WL of at least 10% while on incretin-based therapy and with stable BW for at least 3 months prior to screening.
Key exclusion criteria (6 listed)
- Lifetime history of Type 1 or Type 2 diabetes
- Prior obesity treatment with surgery or a weight loss device.
- Obesity caused by known endocrinologic disorders or by known congenital or acquired hypothalamic disease or monogenetic or syndromic forms of obesity.
- Current or history of (within 3 months prior to screening) treatment with medications that may cause significant weight gain.
- Family or personal history of MTC or MEN 2
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 |
|---|---|---|
| ALV-100Experimental drug | Drug | Dose A - Schedule 1, Dose A - Schedule 2, Dose B - Schedule 1, Dose C - Schedule 1 |
| PlaceboVolume matched placebo | Drug | Dose A - Schedule 1, Dose A - Schedule 2, Dose B - Schedule 1, Dose C - Schedule 1 |
Primary outcome
Dose response of ALV-100 as assessed by maintenance of weight loss
Time frame: 24 weeks
Percentage change from baseline to Week 24 in BW
8 secondary outcomes
Assess the safety and tolerability of ALV-100
Time frame: 36 weeks
Efficacy of ALV-100 compared to placebo as assessed by maintenance of weight loss
Time frame: 24-36 weeks
Change from baseline in glycemic control parameters
Time frame: 24-36 weeks
Change from baseline in lipid parameters
Time frame: 24-36 weeks
Change from baseline in vital signs
Time frame: 24-36 weeks
Immunogenicity of ALV-100
Time frame: 36 weeks
Efficacy of ALV-100 versus placebo on subjective control of eating, food cravings, and mood-related eating behaviors as assessed by the Control of Eating Questionnaire (CoEQ)
Time frame: 24-36 weeks
Effect of ALV-100 vs. placebo on food noise as assessed by the Food Noise Questionnaire (FNQ)
Time frame: 24-36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
20 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 ALV-100 in people with Overweight , Obesity and Adults, run by Alveus Therapeutics, Inc. at 20 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (+1 215-607-2243, clinicaltrials@alveustx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose response of ALV-100 as assessed by maintenance of weight loss (time frame: 24 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 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.