Overweight or Obese AdultsPhase 1NCT07399678
Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without T2D
A Phase 1 study testing ALV-100 in people with Overweight or Obese Adults and Overweight or Obese, Type 2 Diabetes, run by Alveus Therapeutics, Inc. at 3 sites in United States.
Trial summary
A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight or Obese Adults, Overweight or Obese, Type 2 Diabetes
- What is being tested?
- ALV-100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Dec 2025to Oct 2027
- Phase
- Phase 1
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Part A and B
- Adult male and female participants, aged 18 to 65 years, inclusive, at the time of signing the informed consent form
- Body mass index between 27.0 to 39.9 kg/m2 at Screening, both inclusive; overweight should be due to excess adipose tissue, as judged by the Investigator.
- Have a stable body weight (< 5.0 kg/11 lbs self-reported change) within 90 days prior to Screening
- Females must be surgically sterile (by means of bilateral salpingectomy, hysterectomy or bilateral oophorectomy) or be post-menopausal (defined as spontaneous cessation of menses for at least 1 year prior to Screening). Females who are post-menopausal and < 55 years must have a follicle-stimulating hormone level > 40 IU/L at Screening.
- Males with female partners of child-bearing potential must be willing to practice abstinence or must agree to use condom as contraception throughout the duration of the study. This criterion may be waived for male participants who have had a documented successful vasectomy > 6 months before signing the ICF.
Show all 10Show fewer
- For Part B only
- Diagnosis of Type 2 Diabetes for at least 180 days prior to Screening.
- Glycemic control managed by diet and exercise alone or by stable treatment with metformin and/or sodium-glucose cotransporter 2 inhibitors (SGLT-2i), with no dose changes within 3 months prior to Screening.
- Hemoglobin A1c (HbA1c) between 6.5 % and 9.0% (equivalent to 48-75 mmol/mol), both inclusive, at Screening.
Who cannot join
- For Part A and B
- History or presence of any clinically relevant respiratory, metabolic (including dyslipidemia, however screening total cholesterol below or equal to 302 mg/dL (7.8 mmol/L) and/or screening triglyceride below or equal to 500 mg/dL (5.65 mmol/L) is accepted), renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with type 2 diabetes in Part B) at the discretion of the Investigator.
- Participants with a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 or a personal history of nonfamilial medullary thyroid carcinoma.
- Current or history of chronic or acute pancreatitis.
- Obesity caused by known endocrinologic disorders (e.g., Cushing syndrome) or monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome).
- History of major depressive disorder or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or anxiety disorder).
Show all 17Show fewer
- Lifetime history of a suicide attempt or of any suicidal behavior by endorsement of (answered yes to) any of the items in the suicidal behavior section on the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening.
- Systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg at Screening.
- History of or current cardiovascular disease, including but not limited to stable and unstable angina, myocardial infarction, congestive heart failure, transient ischemic attack, stroke, clinically significant arrhythmias and conduction disorders or venous thromboembolism.
- Part A only
- History or clinical evidence of Type 1 or Type 2 diabetes mellitus, including HbA1c ≥ 6.5% and/or a fasting plasma glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) at Screening (female participants with a history of gestational diabetes are allowed).
- Part B only
- Fasting plasma glucose (FPG) > 270 mg/dL (15.0 mmol/L) at Screening.
- Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (within1.5 years from Screening) ophthalmologic examination.
- Severe neuropathy as judged by the investigator.
- Advanced nephropathy (defined as albuminuria ≥ 300 mg/g).
- History of severe hypoglycemia or hypoglycemic unawareness as judged by the investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ohio Clinical Trials
Columbus, Ohio, 43212
Clinical Pharmacology of Miami
Miami, Florida, 33172
Endeavor Clinical Trials
San Antonio, Texas, 78240
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALV-100 in Participants With Overweight or Obesity With or Without Type 2 Diabetes
A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes
- Being tested
- ALV-100, Placebo
- Keywords
- Overweight, Obese, Obesity, Type 2 Diabetes, Weight loss
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALV-100Drug
Participants will receive multiple ascending doses of ALV-100.
PlaceboDrug
Participants will receive placebo matching ALV-100, volume-matched to active dose.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Cohort 1 (ALV-100) | Experimental | Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection. Receives: Drug: ALV-100 |
| Part A - Cohort 1 (Placebo) | Placebo comparator | Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection. Receives: Drug: Placebo |
| Part A - Cohort 2 (ALV-100) | Experimental | Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection. Receives: Drug: ALV-100 |
| Part A - Cohort 2 (Placebo) | Placebo comparator | Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection. Receives: Drug: Placebo |
| Part A - Cohort 3 (ALV-100) | Experimental | Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection. Receives: Drug: ALV-100 |
| Part A - Cohort 3 (Placebo) | Placebo comparator | Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection. Receives: Drug: Placebo |
| Part A - Cohort 4 (ALV-100) | Experimental | Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection. Receives: Drug: ALV-100 |
| Part A - Cohort 4 (Placebo) | Placebo comparator | Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection. Receives: Drug: Placebo |
| Part B - T2D Cohort (ALV-100) | Experimental | Participants with overweight or obesity with type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection. Receives: Drug: ALV-100 |
| Part B - T2D Cohort (Placebo) | Placebo comparator | Participants with overweight or obesity with type 2 diabetes will receive placebo by subcutaneous injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Incidence of treatment emergent adverse events (TEAEs)
Measured: From First Dose to Week 52
Secondary outcomes (10)
Pharmacokinetics (PK) of intact ALV-100 and total ALV-100 - Cmax, MD
Maximum observed serum concentration after multiple doses (MD) (Cmax, MD)
Measured: 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)
Measured: From First Dose to Week 52
Pharmacodynamic (PD) impact on body weight
Change from baseline in body weight
Measured: Baseline, Week 32 and Week 52
Pharmacodynamic (PD) impact on body weight percentage
Change from baseline in body weight percentage
Measured: Baseline, Week 32 and Week 52
Immunogenicity
Incidence of Anti-ALV-100 drug antibodies, including assessments of cross-reactivity and neutralizing antibodies.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Week 32 and Week 52
Hypoglycemic Safety (Part B Only)
Measured by the incidence of symptomatic hypoglycemia, documented symptomatic hypoglycemia and severe hypoglycemia
Measured: From Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start29 Dec 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or Obese AdultsStudies 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
- Sequential
- Model description
- In Part A, four treatment cohorts of participants with overweight or obesity will be administered varying dose escalation regimens of ALV-100. Each cohort will explore the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ALV-100. Each cohort will be comprised of 40 participants with 32 participants receiving active treatment and 8 participants receiving placebo in a 4:1 ratio. In Part B, a single cohort of participants with overweight or obesity, and T2D will be enrolled. This cohort will explore the safety (including glycemic safety), tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of ALV-100. Fifteen (15) participants will receive active treatment, and 5 participants will receive placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alveus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Tornøe, MD, PhD, Study director, Alveus Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399678
- Sponsor's protocol ID
- ALV-102-1
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No