A Phase 1 interventional study of ALV-100 and Placebo in Overweight or Obese Adults and Overweight or Obese, Type 2 Diabetes, sponsored by Alveus Therapeutics, Inc.. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Alveus Therapeutics, Inc. · Phase 1, Interventional, and Treatment
A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 180 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 →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Part A and B
For Part B only
Exclusion Criteria:
For Part A and B
Part A only
Part B only
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.
Drug: ALV-100
Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.
Drug: Placebo
Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.
Drug: ALV-100
Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.
Drug: Placebo
Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.
Drug: ALV-100
Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.
Drug: Placebo
Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.
Drug: ALV-100
Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.
Drug: Placebo
Participants with overweight or obesity with type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.
Drug: ALV-100
Participants with overweight or obesity with type 2 diabetes will receive placebo by subcutaneous injection.
Drug: Placebo
Participants will receive multiple ascending doses of ALV-100.
Participants will receive placebo matching ALV-100, volume-matched to active dose.
Safety and tolerability
Incidence of treatment emergent adverse events (TEAEs)
Time frame: From First Dose to Week 52
Pharmacokinetics (PK) of intact ALV-100 and total ALV-100 - Cmax, MD
Maximum observed serum concentration after multiple doses (MD) (Cmax, MD)
Time frame: From First Dose to Week 52
Pharmacokinetics (PK) of intact ALV-100 and total ALV-100 - AUC(0-τ), MD
Area under the serum concentration-time curve from time zero to τ, where τ is the dosing interval, (AUC(0-τ), MD)
Time frame: From First Dose to Week 52
Pharmacodynamic (PD) impact on body weight
Change from baseline in body weight
Time frame: Baseline, Week 32 and Week 52
Pharmacodynamic (PD) impact on body weight percentage
Change from baseline in body weight percentage
Time frame: Baseline, Week 32 and Week 52
Immunogenicity
Incidence of Anti-ALV-100 drug antibodies, including assessments of cross-reactivity and neutralizing antibodies.
Time frame: From Baseline to Week 52
Relationship between ALV-100 serum concentration and QTc interval changes (Part A Only)
Measurement of change in individual specific heart rate corrected QT interval (QTcI) and Fridericia heart rate corrected QT interval (QTcF) on 12-lead ECG.
Time frame: From First Dose to Week 52
Paracetamol (acetaminophen) absorption test (PAT) (Part A Only)
Measurement of acetaminophen PK parameters to evaluate the effect of ALV-100 on the gastric emptying rate.
Time frame: From First Dose to Week 52
Pharmacodynamic (PD) impact of ALV-100 on antidiabetic medication (Part B Only)
Change in use of concomitant glucose-lowering medication
Time frame: From Baseline to Week 32
Pharmacodynamic (PD) impact of ALV-100 on glycemic parameters (Part B Only)
Measuring the number of participants achieving target Hemoglobin A1c values
Time frame: Week 32 and Week 52
Hypoglycemic Safety (Part B Only)
Measured by the incidence of symptomatic hypoglycemia, documented symptomatic hypoglycemia and severe hypoglycemia
Time frame: From Baseline to Week 52
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Oct 2027, 22 months after the start.
Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 22 months is above that.
Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: primary completion Apr 2027 → Oct 2027 and completion Sep 2027 → Oct 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
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 ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Alveus Therapeutics, Inc.