Health TrialsbyHealthPanel

Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss

ConditionsOverweight , ObesityAdults
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAlveus Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male and female participants, aged ≥18 to ≤75

BMI ≥27 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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALV-100

    Drug

    Experimental drug

  • Placebo

    Drug

    Volume matched placebo

Treatment groups

220 Participants
are divided into 4 treatment groups
Group A: Dose A - Schedule 1Experimental treatment 2 interventions
Group B: Dose B - Schedule 1Experimental treatment 2 interventions
Group C: Dose C - Schedule 1Experimental treatment 2 interventions
Group D: Dose A - Schedule 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alveus Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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