A Phase 2 interventional study of ALV-100 and Placebo in Overweight , Obesity and Adults, sponsored by Alveus Therapeutics, Inc.. Recruiting at 20 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Alveus Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 220 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Alveus Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The criteria were revised on the registry on Oct 26, 2026. See what changed
Key inclusion criteria
Key exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive ALV-100 or volume matched placebo during the treatment period
Drug: ALV-100 · Drug: Placebo
Participants will receive ALV-100 or volume matched placebo during the treatment period
Drug: ALV-100 · Drug: Placebo
Participants will receive ALV-100 or volume matched placebo during the treatment period
Drug: ALV-100 · Drug: Placebo
Participants will receive ALV-100 or volume matched placebo during the treatment period
Drug: ALV-100 · Drug: Placebo
Experimental drug
Volume matched placebo
Dose response of ALV-100 as assessed by maintenance of weight loss
Percentage change from baseline to Week 24 in BW
Time frame: 24 weeks
Assess the safety and tolerability of ALV-100
Incidence of treatment emergent adverse events (TEAE) from first dose administration until Week 36
Time frame: 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 %
Time frame: 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.
Time frame: 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.
Time frame: 24-36 weeks
Change from baseline in vital signs
Change from baseline in systolic and diastolic blood pressure, measured in mmHg.
Time frame: 24-36 weeks
Immunogenicity of ALV-100
Incidence of anti-drug antibodies (ADA) from baseline (pre-dose) until Week 36
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)
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.
Time frame: 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.
Time frame: 24-36 weeks
Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.
Of 176 industry-sponsored phase 2 interventional studies under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 18. This study's planned 12 months is close to that.
Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Alveus Therapeutics, Inc.